xml: <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/NCT05972655</url>
    </required_header>
    <id_info>
      <org_study_id>SRRS-mRCAT</org_study_id>
      <nct_id>NCT05972655</nct_id>
    </id_info>
    <brief_title>Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer</brief_title>
    <acronym>mRCAT</acronym>
    <official_title>Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sir Run Run Shaw Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified&#xD;
        short-course radiation (Radiation targeting the tumor bed without irradiating surrounding&#xD;
        tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for&#xD;
        patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in&#xD;
        this trial. The primary endpoint is the rate of pathological complete response (pCR). The&#xD;
        organ preservation rate, tumor regression grade, long-term prognosis, and adverse effects&#xD;
        will also be analyzed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pathological complete response (pCR) rate</measure>
      <time_frame>within 10 days after surgery</time_frame>
      <description>The status of pCR will be evaluated after the TME surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tumor regression grade</measure>
      <time_frame>within 10 days after surgery</time_frame>
      <description>TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local recurrence rate(LRR)</measure>
      <time_frame>3 years after sugery</time_frame>
      <description>Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease free survival(DFS)</measure>
      <time_frame>3 years after surgery</time_frame>
      <description>The three-year disease-free survival of patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival(OS)</measure>
      <time_frame>3 years after surgery</time_frame>
      <description>The three-year overall survival of patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse effects rate</measure>
      <time_frame>From date of initiation of treatment until the date of death from any cause, assessed up to 5 years</time_frame>
      <description>Rate of radiotherapy, chemotherapy and immunotherapy related adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rectal specific quality of life assessment via QLQ-CR29</measure>
      <time_frame>Baseline and months 3, 6, 12, 24, 36, 60 after the surgery</time_frame>
      <description>Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life assessment via QLQ-C30</measure>
      <time_frame>Baseline and months 3, 6, 12, 24, 36, 60 after the surgery</time_frame>
      <description>Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validation of the Wexner score</measure>
      <time_frame>Months 3, 6, 12, 24, 36, 60 after the surgery</time_frame>
      <description>The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Low Rectal Cancer</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 5*5Gy modified short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 3 cycles, followed by total mesorectal excision surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Modified short-course radiotherapy</intervention_name>
      <description>radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PD-1 antibody</intervention_name>
      <description>PD-1 antibody (Tislelizumab): 200mg d1 q3w</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capecitabine</intervention_name>
      <description>Capecitabine: 1000mg/m2 d1-14 q3w</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxaliplatin</intervention_name>
      <description>Oxaliplatin: 130mg/m2 d1 q3w</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who have a strong willingness to preserve the anus and are willing to receive&#xD;
               neoadjuvant therapy.&#xD;
  &#xD;
            2. Male or Female aged 18-75.&#xD;
  &#xD;
            3. Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the&#xD;
               tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is&#xD;
               cT2N+M0/cT3-4aN0/+M0, the lymph nodes are limited to the mesorectum, the&#xD;
               circumferential resection margin is negative, tumor occupies &lt;2/3 circle of bowel&#xD;
               lumen.&#xD;
  &#xD;
            4. Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS,&#xD;
               or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2&#xD;
               are all positive.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) 0-1.&#xD;
  &#xD;
            6. No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).&#xD;
  &#xD;
            7. Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells&#xD;
               ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L;&#xD;
               activated partial thromboplastin time, prothrombin time and international normalized&#xD;
               ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper&#xD;
               limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine&#xD;
               clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;&#xD;
  &#xD;
            8. Informed consent form signed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a previous history of malignant tumors besides rectal cancer.&#xD;
  &#xD;
            2. Patients with distant metastases before enrollment.&#xD;
  &#xD;
            3. Patients with positive internal or external iliac lymph nodes are assessed by MRI or&#xD;
               CT.&#xD;
  &#xD;
            4. Patients with obstruction, perforation, or bleeding that require emergency surgery.&#xD;
  &#xD;
            5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years.&#xD;
  &#xD;
            6. Allergic to any component of the therapy.&#xD;
  &#xD;
            7. Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or&#xD;
               mucinous adenocarcinoma.&#xD;
  &#xD;
            8. Patients who received immunosuppressive or systemic hormone therapy for&#xD;
               immunosuppressive purposes within 1 month prior to the initiation of therapy.&#xD;
  &#xD;
            9. Patients who have received any other experimental drug (including immunotherapy) or&#xD;
               participated in another interventional clinical trial within 30 days before screening.&#xD;
  &#xD;
           10. Factors leading to study termination, such as alcoholism, drug abuse, other serious&#xD;
               illnesses (including psychiatric disorders) requiring combination therapy, and&#xD;
               patients with severe laboratory abnormalities.&#xD;
  &#xD;
           11. Patients with congenital or acquired immune deficiency (such as HIV infection).&#xD;
  &#xD;
           12. Vulnerable groups, including mentally ill, cognitively impaired, critically ill&#xD;
               patients, minors, pregnant or lactating women, illiterate, etc.&#xD;
  &#xD;
           13. Other conditions that investigators consider not suitable for this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhangfa Song, M.D, PH.D</last_name>
      <phone>+86 13867421652</phone>
      <email>songzhangfa@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cheng Cai, master</last_name>
      <phone>+86 18395995912</phone>
      <email>ColoSurg_cc@zju.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sir Run Run Shao hospital</name>
        <address>
          <city>Hanzhou</city>
          <state>Zhejiang</state>
          <zip>310012</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhangfa Song, Dr</last_name>
        <phone>+86 13867421652</phone>
        <email>songzhangfa@zju.edu.cn</email>
      </contact>
      <investigator>
        <last_name>Zhangfa Song, doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Capecitabine</mesh_term>
      <mesh_term>Oxaliplatin</mesh_term>
      <mesh_term>Antibodies</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972655
  org study id: SRRS-mRCAT
  nct id: NCT05972655
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified
        short-course radiation (Radiation targeting the tumor bed without irradiating surrounding
        tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for
        patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in
        this trial. The primary endpoint is the rate of pathological complete response (pCR). The
        organ preservation rate, tumor regression grade, long-term prognosis, and adverse effects
        will also be analyzed.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pathological complete response (pCR) rate
  time frame: within 10 days after surgery
  description: The status of pCR will be evaluated after the TME surgery.
  measure: Tumor regression grade
  time frame: within 10 days after surgery
  description: TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.
  measure: Local recurrence rate(LRR)
  time frame: 3 years after sugery
  description: Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.
  measure: Disease free survival(DFS)
  time frame: 3 years after surgery
  description: The three-year disease-free survival of patients.
  measure: Overall survival(OS)
  time frame: 3 years after surgery
  description: The three-year overall survival of patients.
  measure: Adverse effects rate
  time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
  description: Rate of radiotherapy, chemotherapy and immunotherapy related adverse events
  measure: Rectal specific quality of life assessment via QLQ-CR29
  time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the surgery
  description: Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.
  measure: Quality of life assessment via QLQ-C30
  time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the surgery
  description: Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.
  measure: Validation of the Wexner score
  time frame: Months 3, 6, 12, 24, 36, 60 after the surgery
  description: The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.
  arm group label: Treatment Arm
  arm group type: Experimental
  description: Participants will receive 5*5Gy modified short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 3 cycles, followed by total mesorectal excision surgery.
  intervention type: Radiation
  intervention name: Modified short-course radiotherapy
  description: radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
  arm group label: Treatment Arm
  intervention type: Drug
  intervention name: PD-1 antibody
  description: PD-1 antibody (Tislelizumab): 200mg d1 q3w
  arm group label: Treatment Arm
  intervention type: Drug
  intervention name: Capecitabine
  description: Capecitabine: 1000mg/m2 d1-14 q3w
  arm group label: Treatment Arm
  intervention type: Drug
  intervention name: Oxaliplatin
  description: Oxaliplatin: 130mg/m2 d1 q3w
  arm group label: Treatment Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhangfa Song, M.D, PH.D
  phone: +86 13867421652
  email: songzhangfa@zju.edu.cn
  last name: Cheng Cai, master
  phone: +86 18395995912
  email: ColoSurg_cc@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Rectal Neoplasms
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  mesh term: Antibodies