<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/NCT04443296</url>
  </required_header>
  <id_info>
    <org_study_id>SYSGO008</org_study_id>
    <nct_id>NCT04443296</nct_id>
  </id_info>
  <brief_title>Study of Tumor Infiltrating Lymphocytes Following CCRT in the Treatment of Patients With Cervical Carcinoma</brief_title>
  <acronym>TIL-Cx</acronym>
  <official_title>Study of Tumor Infiltrating Lymphocytes Following Concurrent Chemoradiotherapy in the Treatment of Patients With Cervical Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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>
      A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin&#xD;
      concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA&#xD;
      cervical carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced&#xD;
      cervical cancer, while the incidence of treatment failure is still high. Adjuvant&#xD;
      chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient&#xD;
      survival compared to CCRT alone. Hence, there is a need for novel therapies to improve&#xD;
      survival for these patients.&#xD;
&#xD;
      Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor&#xD;
      recognition and greatly expanded in vitro are effective for treating cervical cancer&#xD;
      patients.&#xD;
&#xD;
      This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin&#xD;
      concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA&#xD;
      cervical carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 12, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 1</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>Toxicity Evaluation</measure>
    <time_frame>From chemo-radiotherapy start until Day30 after TIL infusion</time_frame>
    <description>Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of CCRT in combination with TIL successful infusion</measure>
    <time_frame>30 days after start of TIL-ACT infusion</time_frame>
    <description>Number of patients receiving a complete TIL infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
    <description>Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
    <description>Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response or stable disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control time (DCT)</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
    <description>Duration from complete response, partial response or stable disease to progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological correlates to tumor response</measure>
    <time_frame>1, 3, 6, 9, 12 months</time_frame>
    <description>Post-hoc exploratory analyses for immunological correlates to tumor response.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Cervical Carcinoma</condition>
  <arm_group>
    <arm_group_label>CCRT+TIL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CCRT+TIL</intervention_name>
    <description>Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy</description>
    <arm_group_label>CCRT+TIL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically proven squamous cell carcinoma, adenocarcinoma or&#xD;
             adenosquamous carcinoma of the cervical uteri&#xD;
&#xD;
          -  Patients with stage IIIA-IVA cervical cancer according to the International Federation&#xD;
             of Gynecology and Obstetrics (FIGO)&#xD;
&#xD;
          -  Patients who were ≥ 18 and ≤ 70 years old&#xD;
&#xD;
          -  Patients with an ECOG performance status of 0, 1, or 2&#xD;
&#xD;
          -  Adequate hematological, renal, and hepatic functions defined as:&#xD;
&#xD;
        granulocytes ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, total bilirubin, ALT and AST ≤ 1.5 x&#xD;
        upper normal limit, creatinine ≤ upper normal limit&#xD;
&#xD;
          -  Patients provided written, voluntary informed consent&#xD;
&#xD;
          -  Patients who were accessible to follow up and management in the treatment center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with past or current history of malignancy other than the entry diagnosis&#xD;
             except for a &quot;cured&quot; malignancy more than five years prior to enrollment&#xD;
&#xD;
          -  Patients who received previous chemotherapy or radiotherapy&#xD;
&#xD;
          -  Patients with active angina or documented myocardial infarction within the 6 months&#xD;
             preceding registration and patients with a history of significant ventricular&#xD;
             arrhythmia requiring medication or congestive heart failure, as well as a history of&#xD;
             2nd or 3rd degree heart blocks&#xD;
&#xD;
          -  Patients with an active infection or other serious underlying medical conditions that&#xD;
             would impair the ability of the patient to receive the planned treatment, including&#xD;
             prior allergic reactions to drugs containing platinum&#xD;
&#xD;
          -  Patients with dementia or altered mental status that would prohibit the understanding&#xD;
             and providing of informed consent&#xD;
&#xD;
          -  Patients with inadequate caloric and/or fluid intake&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jihong Liu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>November 13, 2021</last_update_submitted>
  <last_update_submitted_qc>November 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jihong Liu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Tumor Infiltrating Lymphocytes</keyword>
  <keyword>Concurrent chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
  </condition_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/NCT04443296
org study id: SYSGO008
nct id: NCT04443296
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin
      concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA
      cervical carcinoma.
Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced
      cervical cancer, while the incidence of treatment failure is still high. Adjuvant
      chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient
      survival compared to CCRT alone. Hence, there is a need for novel therapies to improve
      survival for these patients.

      Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor
      recognition and greatly expanded in vitro are effective for treating cervical cancer
      patients.

      This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin
      concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA
      cervical carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicity Evaluation
time frame: From chemo-radiotherapy start until Day30 after TIL infusion
description: Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
measure: Feasibility of CCRT in combination with TIL successful infusion
time frame: 30 days after start of TIL-ACT infusion
description: Number of patients receiving a complete TIL infusion
measure: Objective Response Rate (ORR)
time frame: 1, 3, 6, 9, 12 months
description: Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response.
measure: Disease control rate (DCR)
time frame: 1, 3, 6, 9, 12 months
description: Disease response evaluated after the completion of the chemoradiotherapy and TIL treatment. Achievement of complete response, partial response or stable disease.
measure: Disease control time (DCT)
time frame: 1, 3, 6, 9, 12 months
description: Duration from complete response, partial response or stable disease to progression.
measure: Immunological correlates to tumor response
time frame: 1, 3, 6, 9, 12 months
description: Post-hoc exploratory analyses for immunological correlates to tumor response.
arm group label: CCRT+TIL
arm group type: Experimental
description: Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
intervention type: Drug
intervention name: CCRT+TIL
description: Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy
arm group label: CCRT+TIL
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jihong Liu, MD
role: Study Director
affiliation: Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Jihong Liu
investigator title: Professor
mesh term: Carcinoma
sharing ipd: No