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/NCT05998122</url>
    </required_header>
    <id_info>
      <org_study_id>STARS-RC06</org_study_id>
      <nct_id>NCT05998122</nct_id>
    </id_info>
    <brief_title>Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study</brief_title>
    <official_title>Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Hospital of Jilin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Hospital of Jilin University</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>
        Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044)&#xD;
        conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining&#xD;
        with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety&#xD;
        profile contrasted with 3-cycle counterparts. Herein, we designed this study to further&#xD;
        evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term&#xD;
        survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The combination of total neoadjuvant treatment (TNT) and immunotherapy has shown a&#xD;
        significant improvement in the pCR rate compared to the standard of care (SOC) or TNT alone&#xD;
        for pMMR LARC. On this basis, we believe that this treatment mode will offers the opportunity&#xD;
        of organ preservation for subperitoneal &quot;Bad&quot; or &quot;Advanced&quot; patients with LARC, who are&#xD;
        initially assessed as unresectable or difficult to obtain R0 resection. Previously,&#xD;
        preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our&#xD;
        research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1&#xD;
        therapy had a better tumor regression advantage with a restricted safety profile contrasted&#xD;
        with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term&#xD;
        efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS,&#xD;
        OS, etc.) of 6-cycles consolidation therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>Complete response rate (CR)</measure>
      <time_frame>Within one week after Last treatment</time_frame>
      <description>defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease-Free Survival (DFS)</measure>
      <time_frame>1/2/3 years from the date of receiving neoadjuvant therapy</time_frame>
      <description>1/2/3 years disease-free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence -Free Survival (RFS)</measure>
      <time_frame>1/2/3 years from the date of receiving neoadjuvant therapy</time_frame>
      <description>1/2/3 years recurrence -free survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>3 years from the date of receiving neoadjuvant therapy</time_frame>
      <description>3 years overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local Recurrence (LR) Rate</measure>
      <time_frame>2 years from the date of receiving neoadjuvant therapy</time_frame>
      <description>2-year local recurrence rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Organ preservation rate</measure>
      <time_frame>1/2/3 years from the date of receiving neoadjuvant therapy</time_frame>
      <description>Organ preservation rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>R0 Resection rate</measure>
      <time_frame>Within one week after surgery</time_frame>
      <description>R0 Resection rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of serious adverse events</measure>
      <time_frame>Within 3 months after Last medication</time_frame>
      <description>Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QLQ-C30 score</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Quality of Life Questionnaire C30</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QLQ-C29 score</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Quality of Life Questionnaire C29</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low Anterior Resection Syndrome (LARS)</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Low Anterior Resection Syndrome Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life and function assessment</measure>
      <time_frame>up to 12 months</time_frame>
      <description>IIEF-5 (international questionnaire of erectile function-5)score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wexner score</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Wexner incontinence score</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Locally Advanced Rectal Cancer</condition>
    <condition>Total Neoadjuvant Treatment</condition>
    <condition>Anti-PD-1</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).&#xD;
  Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).&#xD;
  Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&amp;W</intervention_name>
      <description>Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).&#xD;
  Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).&#xD;
  Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patients and their families are able to understand and are willing to participate&#xD;
               in this clinical study, and sign an informed consent form.&#xD;
  &#xD;
            2. Age: 18~75 years old, no gender limit;&#xD;
  &#xD;
            3. Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that&#xD;
               is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as&#xD;
               pMMR/MSS.&#xD;
  &#xD;
            4. The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines,&#xD;
               2017 edition) is as follows: 1) &quot;Bad&quot;: cT3c/d or very low localisation levators&#xD;
               threatened, MRF clear; cT3c/d mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0;&#xD;
               2) &quot;Advanced&quot;: cT3 with any MRF involved, any cT4a/b, lateral node+.&#xD;
  &#xD;
            5. The lower edge of the tumor is located below the peritoneal reflex;&#xD;
  &#xD;
            6. No distant transfer;&#xD;
  &#xD;
            7. ECOG PS score 0-1 within 7 days before the first medication;&#xD;
  &#xD;
            8. Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-). If&#xD;
               HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be less&#xD;
               than 1000 copies/mL or 200 IU/mL before entering the group.&#xD;
  &#xD;
            9. HCV antibody (-)&#xD;
  &#xD;
           10. The main organ function is normal.&#xD;
  &#xD;
           11. No history of pelvic radiotherapy;&#xD;
  &#xD;
           12. No history of rectal cancer surgery or chemotherapy;&#xD;
  &#xD;
           13. Not accompanied by systemic infections requiring antibiotic treatment;&#xD;
  &#xD;
           14. Heart, lung, liver, and kidney functions can tolerate surgery;&#xD;
  &#xD;
           15. Others, based on the results of previous medical history, vital signs, physical&#xD;
               examination or laboratory examination, the research doctor judges that you are&#xD;
               suitable for participating in this clinical study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Recurrent rectal cancer;&#xD;
  &#xD;
            2. Patients who are planning to undergo or have previously received organ or bone marrow&#xD;
               transplantation;&#xD;
  &#xD;
            3. Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms&#xD;
               for males and ≥ 470 ms for females) occurred within 6 months before the first&#xD;
               medication (QTc interval is calculated by Fridericia formula);&#xD;
  &#xD;
            4. Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler&#xD;
               ultrasound examination: LVEF (left ventricular ejection fraction) &lt;50%;&#xD;
  &#xD;
            5. Human immunodeficiency virus (HIV) infection;&#xD;
  &#xD;
            6. Suffer from active tuberculosis;&#xD;
  &#xD;
            7. Past and present patients with interstitial pneumonia, pneumoconiosis, radiation&#xD;
               pneumonia, drug-related pneumonia, severely impaired lung function, etc., which may&#xD;
               interfere with the detection and treatment of suspected drug-related lung toxicity;&#xD;
  &#xD;
            8. Patients with active or suspicious autoimmune disease, or with a history of that;&#xD;
  &#xD;
            9. Received treatment with live vaccines within 28 days before the first administration;&#xD;
               except for inactivated viral vaccines for seasonal influenza;&#xD;
  &#xD;
           10. Have received other antibody/drug treatments against immune checkpoints in the past,&#xD;
               such as PD-1, PD-L1, CTLA4, etc.;&#xD;
  &#xD;
           11. Known to have a history of severe allergies to any monoclonal antibody or research&#xD;
               drug excipients;&#xD;
  &#xD;
           12. In the past 5 years, patients have suffered from malignant tumors whose survival rate&#xD;
               is significantly lower than the historical data of our rectal cancer survival rate&#xD;
               (properly treated basal cell carcinoma, skin squamous cell carcinoma, small kidney&#xD;
               cancer, breast cancer, and papillary thyroid carcinoma are not included here. range);&#xD;
  &#xD;
           13. The patient has had arterial embolism diseases in the past 6 months, such as angina&#xD;
               pectoris, MI, TIA, CVA, etc.;&#xD;
  &#xD;
           14. Have received other types of anti-tumor or experimental treatments;&#xD;
  &#xD;
           15. The patient is a female during pregnancy or lactation;&#xD;
  &#xD;
           16. The patient has other diseases or abnormal mental states, which may affect the&#xD;
               patient's participation in this study;&#xD;
  &#xD;
           17. There are patients who may increase the risk of participating in research and research&#xD;
               medication, or other severe, acute and chronic diseases, who are not suitable for&#xD;
               clinical research based on the judgment of the investigator.&#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>Wang Quan, Prof.</last_name>
      <phone>+86-431-81875602</phone>
      <email>wquan@jlu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>PengYu Chang, Prof.</last_name>
      <email>changpengyu@mails.jlu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Ji Lin</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
      <investigator_full_name>Quan Wang</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05998122
  org study id: STARS-RC06
  nct id: NCT05998122
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044)
        conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining
        with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety
        profile contrasted with 3-cycle counterparts. Herein, we designed this study to further
        evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term
        survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
  The combination of total neoadjuvant treatment (TNT) and immunotherapy has shown a
        significant improvement in the pCR rate compared to the standard of care (SOC) or TNT alone
        for pMMR LARC. On this basis, we believe that this treatment mode will offers the opportunity
        of organ preservation for subperitoneal "Bad" or "Advanced" patients with LARC, who are
        initially assessed as unresectable or difficult to obtain R0 resection. Previously,
        preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our
        research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1
        therapy had a better tumor regression advantage with a restricted safety profile contrasted
        with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term
        efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS,
        OS, etc.) of 6-cycles consolidation therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete response rate (CR)
  time frame: Within one week after Last treatment
  description: defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.
  measure: Disease-Free Survival (DFS)
  time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
  description: 1/2/3 years disease-free survival
  measure: Recurrence -Free Survival (RFS)
  time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
  description: 1/2/3 years recurrence -free survival
  measure: Overall Survival (OS)
  time frame: 3 years from the date of receiving neoadjuvant therapy
  description: 3 years overall survival
  measure: Local Recurrence (LR) Rate
  time frame: 2 years from the date of receiving neoadjuvant therapy
  description: 2-year local recurrence rate
  measure: Organ preservation rate
  time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
  description: Organ preservation rate
  measure: R0 Resection rate
  time frame: Within one week after surgery
  description: R0 Resection rate
  measure: The incidence of serious adverse events
  time frame: Within 3 months after Last medication
  description: Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 5.0.
  measure: QLQ-C30 score
  time frame: up to 12 months
  description: Quality of Life Questionnaire C30
  measure: QLQ-C29 score
  time frame: up to 12 months
  description: Quality of Life Questionnaire C29
  measure: Low Anterior Resection Syndrome (LARS)
  time frame: up to 12 months
  description: Low Anterior Resection Syndrome Questionnaire
  measure: Quality of life and function assessment
  time frame: up to 12 months
  description: IIEF-5 (international questionnaire of erectile function-5)score
  measure: Wexner score
  time frame: up to 12 months
  description: Wexner incontinence score
  arm group label: Experimental
  arm group type: Experimental
  description: Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).
  Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).
  Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.
  intervention type: Other
  intervention name: nCRT → (CapeOX+Sintilimab)×6 → Surgery/W&W
  description: Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w).
  Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1).
  Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Wang Quan, Prof.
  phone: +86-431-81875602
  email: wquan@jlu.edu.cn
  last name: PengYu Chang, Prof.
  email: changpengyu@mails.jlu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Hospital of Jilin University
  investigator full name: Quan Wang
  investigator title: Prof.
  mesh term: Rectal Neoplasms
  sharing ipd: Undecided