<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03777930</url>
  </required_header>
  <id_info>
    <org_study_id>shenzhenfifth 201807</org_study_id>
    <nct_id>NCT03777930</nct_id>
  </id_info>
  <brief_title>The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol</brief_title>
  <official_title>Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen Fifth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen Fifth People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To observe the effect of thalidomide combined with megestrol acetate on lymphocyte,&#xD;
      inflammatory factor regulation and nutritional status in patients with advanced malignant&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2&#xD;
      months. 50 patients were randomly assigned to each group. The patients were divided into&#xD;
      chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The&#xD;
      best supportive treatment group, the best supportive treatment combined with thalidomide and&#xD;
      megestrol acetate group. The chemotherapy group and the best supportive treatment group were&#xD;
      the control group. The combined group was administered continuously for 8 weeks according to&#xD;
      thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest&#xD;
      diameters of the target lesions from each patient before and 8 week after treatment. Patients&#xD;
      in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell&#xD;
      subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional&#xD;
      assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life&#xD;
      Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status&#xD;
      Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm&#xD;
      muscle area analysis of the effect of thalidomide combined with megestrol acetate on the&#xD;
      nutritional status of patients with advanced cancer which reveal that thalidomide combined&#xD;
      with megestrol acetate may improve the immune regulation and nutritional status of patients&#xD;
      with advanced malignant tumors mechanism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 10, 2018</start_date>
  <completion_date type="Anticipated">June 10, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 10, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Imaging efficacy evaluation</measure>
    <time_frame>before and 8 week after treatment</time_frame>
    <description>Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observing the expression of lymphocyte subsets</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observing the expression of inflammatory factors</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional assessment</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Multidimensional deficient power assessment</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>Multidimensional deficient power assessment (MFSI-SF) was used in the present study. The MFSI-SF scale contains 30 subjects' subjective feelings，such as muscle soreness and memory loss. Subjects were scored according to the degree of each sensation (0-4). The MFSI-SF scale total score is the sum of each sensation score (0-120). The lower scores represent a better outcome and the higher scores represent a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>Quality of Life Assessment Table (EORTC QLQ-C30) was used in the present study. The Quality of Life Assessment Table contains 28 subjects' subjective feelings and symptoms，such as tiredness and diarrhea within one week (A)，and two other indicators: health status，quality of life within one week (B). Subjects were scored according to the degree of each sensation (A 0-4) and (B 1-7). The Quality of Life Assessment Table is divided into two parts: the first part of the total score (0-112); the second part of the total scores (2-14). In the first part of the total scores: the lower scores represent a better outcome and the higher scores represent a worse outcome. In the second part of the total scores: the higher scores represent a better outcome and the lower scores represent a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Prognostic assessment</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>The prognostic assessment by GPS scores which were calculated by detecting peripheral blood CRP and albumin from each tumor patients.&#xD;
GPS scores：CRP &lt; 10 mg/l，albumin&gt; 35g/l，GPS 0；CRP &gt; 10 mg/l，albumin &gt; 35 g/l，GPS 1；CRP &gt; 10 mg/l，albumin &lt; 35 g/l，GPS 2. The lower scores represent a better outcome and the higher scores represent a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Performance status assessment</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>The performance status of patients with cancer is measured by the clinician through the ECOG score form (score:0-5)</description>
  </other_outcome>
  <other_outcome>
    <measure>Lean body mass</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>Patient's waist circumference and weight were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate lean body mass by measurements of waist circumference and body weight</description>
  </other_outcome>
  <other_outcome>
    <measure>Upper arm muscle circumference and upper arm muscle area</measure>
    <time_frame>before , the fourth and the seventh weeks of treatment</time_frame>
    <description>Patient's upper arm circumference and triceps skinfold thickness were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate Upper arm muscle circumference and upper arm muscle area by measurements of upper arm circumference and triceps skinfold thickness</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cancer, Therapy-Related</condition>
  <arm_group>
    <arm_group_label>chemotherapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients were recepted chemotherapy alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chemotherapy combined with TH and MG group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients were recepted chemotherapy combined with thalidomide and megestrol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the best supportive treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients were recepted the best supportive without chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the best supportive treatment combined with TH and MG group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy drugs</intervention_name>
    <description>According to the NCCN Guidelines</description>
    <arm_group_label>chemotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>thalidomide and megestrol acetate</intervention_name>
    <description>The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks</description>
    <arm_group_label>chemotherapy combined with TH and MG group</arm_group_label>
    <other_name>Chemotherapy drugs</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>optimal support treatment</intervention_name>
    <description>Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks</description>
    <arm_group_label>the best supportive treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>thalidomide and megestrol acetate</intervention_name>
    <description>The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks</description>
    <arm_group_label>the best supportive treatment combined with TH and MG group</arm_group_label>
    <other_name>optimal support treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced malignant tumor confirmed by histopathology or cytology&#xD;
             (hepatocarcinoma can be clinical diagnosis)&#xD;
&#xD;
          -  Must be able to swallow pills&#xD;
&#xD;
          -  The age of the tester ≥ 18 years old&#xD;
&#xD;
          -  Gender is not limited&#xD;
&#xD;
          -  Kamofsky score &gt; 20 points&#xD;
&#xD;
          -  Estimated survival period ≥ 2 months&#xD;
&#xD;
          -  Childbearing age Women need negative pregnancy test&#xD;
&#xD;
          -  Patients voluntarily sign informed consent and receive follow-up&#xD;
&#xD;
          -  The tester can cooperate to observe adverse events and efficacy&#xD;
&#xD;
          -  All of the above conditions can be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active upper digestive tract ulcers, obvious vomiting, chronic diarrhea, intestinal&#xD;
             obstruction, malabsorption, etc; other patients have been known to affect drug&#xD;
             absorption, distribution, metabolism or clearance&#xD;
&#xD;
          -  2 or more important organ dysfunction&#xD;
&#xD;
          -  Thrombosis Embolism history, except for thrombosis caused by PICC&#xD;
&#xD;
          -  Patients suspected of having a history of allergy to thalidomide tablets&#xD;
&#xD;
          -  Any significant clinical and laboratory abnormalities that researchers believe affect&#xD;
             safety evaluators, such as: uncontrollable activity Microbial infection, grade II or&#xD;
             above peripheral neuropathy (NCI CTC AE v4.0), congestive heart failure, myocardial&#xD;
             infarction within 6 months, chronic kidney disease, thyroid dysfunction etc, and&#xD;
             acceptance may bring significant metabolic or weight changes Patients with clinical&#xD;
             disposition&#xD;
&#xD;
          -  Patients with mental disorders, affecting the efficacy of the assessor&#xD;
&#xD;
          -  During the trial period and within 3 months after the end of the trial, the subject&#xD;
             and his partner are not willing to contraception&#xD;
&#xD;
          -  Any of the above can not be enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>yangwei w yang, master</last_name>
    <phone>13826524554</phone>
    <phone_ext>0755-82646002</phone_ext>
    <email>junweiyang@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>wenbin wb gao, doctor</last_name>
    <phone>13266778968</phone>
    <phone_ext>0755-82646002</phone_ext>
    <email>drwenbingao@163.com</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thalidomide</keyword>
  <keyword>megestrol acetate</keyword>
  <keyword>tumor</keyword>
  <keyword>lymphocyte</keyword>
  <keyword>inflammatory cytokines</keyword>
  <keyword>nutritional</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms, Second Primary</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
    <mesh_term>Megestrol</mesh_term>
    <mesh_term>Megestrol Acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777930
org study id: shenzhenfifth 201807
nct id: NCT03777930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To observe the effect of thalidomide combined with megestrol acetate on lymphocyte,
      inflammatory factor regulation and nutritional status in patients with advanced malignant
      tumors.
This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2
      months. 50 patients were randomly assigned to each group. The patients were divided into
      chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The
      best supportive treatment group, the best supportive treatment combined with thalidomide and
      megestrol acetate group. The chemotherapy group and the best supportive treatment group were
      the control group. The combined group was administered continuously for 8 weeks according to
      thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest
      diameters of the target lesions from each patient before and 8 week after treatment. Patients
      in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell
      subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional
      assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life
      Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status
      Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm
      muscle area analysis of the effect of thalidomide combined with megestrol acetate on the
      nutritional status of patients with advanced cancer which reveal that thalidomide combined
      with megestrol acetate may improve the immune regulation and nutritional status of patients
      with advanced malignant tumors mechanism.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Imaging efficacy evaluation
time frame: before and 8 week after treatment
description: Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.
measure: Observing the expression of lymphocyte subsets
time frame: before , the fourth and the seventh weeks of treatment
description: Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)
measure: Observing the expression of inflammatory factors
time frame: before , the fourth and the seventh weeks of treatment
description: 2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)
measure: Nutritional assessment
time frame: before , the fourth and the seventh weeks of treatment
description: Scored Patient-Generated Subjiective Global Assessment（PG-SGA）form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores（A+B+C+D）. The first measurement score（A）is self-assessed by the subject and consists of the following four parts: Weight Table（0-4），Eating Situation Table（0-6），Symptom Table （0-22），Activity and Body Function Table（0-3）. The remaining three measurements are completed by trained registered clinical physicians， dieticians，and nurses: Scale of relationship between disease and nutritional needs（B）（0-6），Metabolic demand scale（C）（0-9），Physical examination scale（D）（0-24）. The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.
measure: Multidimensional deficient power assessment
time frame: before , the fourth and the seventh weeks of treatment
description: Multidimensional deficient power assessment (MFSI-SF) was used in the present study. The MFSI-SF scale contains 30 subjects' subjective feelings，such as muscle soreness and memory loss. Subjects were scored according to the degree of each sensation (0-4). The MFSI-SF scale total score is the sum of each sensation score (0-120). The lower scores represent a better outcome and the higher scores represent a worse outcome.
measure: Quality of life assessment
time frame: before , the fourth and the seventh weeks of treatment
description: Quality of Life Assessment Table (EORTC QLQ-C30) was used in the present study. The Quality of Life Assessment Table contains 28 subjects' subjective feelings and symptoms，such as tiredness and diarrhea within one week (A)，and two other indicators: health status，quality of life within one week (B). Subjects were scored according to the degree of each sensation (A 0-4) and (B 1-7). The Quality of Life Assessment Table is divided into two parts: the first part of the total score (0-112); the second part of the total scores (2-14). In the first part of the total scores: the lower scores represent a better outcome and the higher scores represent a worse outcome. In the second part of the total scores: the higher scores represent a better outcome and the lower scores represent a worse outcome.
measure: Prognostic assessment
time frame: before , the fourth and the seventh weeks of treatment
description: The prognostic assessment by GPS scores which were calculated by detecting peripheral blood CRP and albumin from each tumor patients.
GPS scores：CRP < 10 mg/l，albumin> 35g/l，GPS 0；CRP > 10 mg/l，albumin > 35 g/l，GPS 1；CRP > 10 mg/l，albumin < 35 g/l，GPS 2. The lower scores represent a better outcome and the higher scores represent a worse outcome.
measure: Performance status assessment
time frame: before , the fourth and the seventh weeks of treatment
description: The performance status of patients with cancer is measured by the clinician through the ECOG score form (score:0-5)
measure: Lean body mass
time frame: before , the fourth and the seventh weeks of treatment
description: Patient's waist circumference and weight were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate lean body mass by measurements of waist circumference and body weight
measure: Upper arm muscle circumference and upper arm muscle area
time frame: before , the fourth and the seventh weeks of treatment
description: Patient's upper arm circumference and triceps skinfold thickness were measured by trained registered clinical dietitians, and the measuring was controlled by one researcher (H.R). The researcher calculate Upper arm muscle circumference and upper arm muscle area by measurements of upper arm circumference and triceps skinfold thickness
arm group label: chemotherapy group
arm group type: Experimental
description: the patients were recepted chemotherapy alone
arm group label: chemotherapy combined with TH and MG group
arm group type: Experimental
description: the patients were recepted chemotherapy combined with thalidomide and megestrol
arm group label: the best supportive treatment group
arm group type: Experimental
description: the patients were recepted the best supportive without chemotherapy
arm group label: the best supportive treatment combined with TH and MG group
arm group type: Experimental
description: the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy
intervention type: Drug
intervention name: Chemotherapy drugs
description: According to the NCCN Guidelines
arm group label: chemotherapy group
intervention type: Drug
intervention name: thalidomide and megestrol acetate
description: The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
arm group label: chemotherapy combined with TH and MG group
other name: Chemotherapy drugs
intervention type: Other
intervention name: optimal support treatment
description: Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
arm group label: the best supportive treatment group
intervention type: Drug
intervention name: thalidomide and megestrol acetate
description: The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
arm group label: the best supportive treatment combined with TH and MG group
other name: optimal support treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: yangwei w yang, master
phone: 13826524554
phone ext: 0755-82646002
email: junweiyang@163.com
last name: wenbin wb gao, doctor
phone: 13266778968
phone ext: 0755-82646002
email: drwenbingao@163.com
responsible party type: Sponsor
mesh term: Neoplasms, Second Primary
mesh term: Thalidomide
mesh term: Megestrol
mesh term: Megestrol Acetate
sharing ipd: No