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/NCT05969847</url>
    </required_header>
    <id_info>
      <org_study_id>2023XHYG0026-01</org_study_id>
      <nct_id>NCT05969847</nct_id>
    </id_info>
    <brief_title>Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer</brief_title>
    <acronym>TRACE-LE</acronym>
    <official_title>Total Neoadjuvant Therapy With Split-course Hypofraction Radiotherapy Combined With CAPOX and Envafolimab Followed by Local Excision for Locally Advanced Very Low Rectal Cancer: an Open-label, Single-arm, Multi-center, Phase II Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>池畔</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Medical University Union 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>
        Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in&#xD;
        a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of&#xD;
        preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy&#xD;
        and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical&#xD;
        complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local&#xD;
        full-thickness resection was implemented.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Locally advanced very low rectal cancer poses significant challenges in rectal cancer&#xD;
        treatment. Presently, the prevailing approach in clinical practice involves neoadjuvant&#xD;
        chemoradiotherapy in conjunction with total mesorectal excision (TME). Historically,&#xD;
        abdominoperineal resection (APR) has been the conventional surgical procedure for managing&#xD;
        locally advanced very low rectal cancer. However, the long-term presence of a colostomy&#xD;
        following an abdominoperineal resection (APR) significantly impacts the quality of life for&#xD;
        patients. Additionally, studies have revealed that 11.8-22% of rectal cancer patients who&#xD;
        underwent APR after neoadjuvant chemoradiotherapy (nCRT) achieved a pathological complete&#xD;
        response (pCR). Conversely, 11-52% of patients with pCR after nCRT for rectal cancer&#xD;
        ultimately underwent APR surgery. Intersphincter resection (ISR) offers a highly beneficial&#xD;
        surgical approach that preserves the anal sphincter, particularly for individuals with&#xD;
        locally advanced very low rectal cancer. The patient's postoperative quality of life was&#xD;
        significantly affected by severe low anterior resection syndrome (LARS), sexual dysfunction,&#xD;
        and voiding dysfunction.&#xD;
  &#xD;
        This study represents an exploratory phase II clinical trial in which patients diagnosed with&#xD;
        locally advanced very low rectal cancer were chosen to undergo a total neoadjuvant therapy&#xD;
        (TNT) regimen. This regimen consisted of preoperative fractionated radiotherapy (5×7Gy)&#xD;
        combined with 6 cycles of CAPOX chemotherapy and enverolimab.&#xD;
  &#xD;
        For patients who achieved clinical complete response (cCR) or near-clinical complete response&#xD;
        (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness&#xD;
        resection was implemented. Patients who achieve non-clinical complete response are subjected&#xD;
        to traditional TME surgery.&#xD;
  &#xD;
        This study aims to investigate the effectiveness and safety of organ preservation using the&#xD;
        local resection approach in patients with locally advanced very low rectal cancer. By&#xD;
        implementing this approach, the study aims to improve the quality of life for patients who&#xD;
        achieve pathological complete response (pCR), thereby avoiding the need for conventional&#xD;
        abdominoperineal resection (APR) and intersphincteric resection (ISR) procedures.&#xD;
        Additionally, this study aims to address the issue of local regrowth associated with the&#xD;
        &quot;watch &amp; wait&quot; strategy and propose a novel treatment strategy for rectal-sparing surgery in&#xD;
        patients with locally advanced very low rectal cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</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>Organ preservation</measure>
      <time_frame>36 months</time_frame>
      <description>The rectum is intact, owing to no radical total mesorectal excision (TME), curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma or a stoma owing to toxicities and/or poor functional outcomes).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ypT0-1 rate</measure>
      <time_frame>36 months</time_frame>
      <description>The proportion of subjects with primary rectal cancer assessed by hematoxylin and eosin staining including no evidence of primary tumor (T0) or carcinoma in situ: intramucosal carcinoma (invading lamina propria, not infiltrating muscularis mucosa) (Tis) or tumor invading submucosa (T1) (ypT0-1 based on the latest UICC/AJCC staging system)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pathological complete response (pCR) rate</measure>
      <time_frame>36 months</time_frame>
      <description>Proportion of subjects with primary rectal cancer and all sampled lymph nodes who did not find any invasive carcinoma and high-grade intraepithelial neoplasia/severe dysplasia after assessment by hematoxylin and eosin staining (Judged as ypT0N0 stage according to the latest UICC/AJCC staging system)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute and late toxicity</measure>
      <time_frame>36 months</time_frame>
      <description>Acute and late toxicity, Incidence of Treatment-Emergent Adverse Events assessment according to NCICTCAE V.5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local recurrence rate</measure>
      <time_frame>36months</time_frame>
      <description>The proportion of patients in all subjects within 3 years from the start of the surgery to detection of a tumor involving the bowel wall only that occurs after LE or TME</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local regional recurrence rate</measure>
      <time_frame>36 months</time_frame>
      <description>The proportion of patients in all subjects within 3 years from the start of the surgery to detection of a tumor involving either the bowel wall, mesorectum, and/or pelvic organs that occurs after LE or TME</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>36 months</time_frame>
      <description>The proportion of patients in all subjects within 3 years from the start of the surgery to recurrence, distant metastsis, or death from any cause (whichever occurs first)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life-based on EORTC QLQ-C30 and EORTC QLQ-CR29</measure>
      <time_frame>baseline, 3 months, 12 months, 24 months, and 36 months after LE or TME</time_frame>
      <description>Quality of life measured using EORTC QLQ-C30 and EORTC QLQ-CR29</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anorectal function</measure>
      <time_frame>baseline, 3 months, 12 months, 24 months, and 36 months after LE or TME</time_frame>
      <description>Anorectal function based on LARS score</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Rectal Cancer</condition>
    <arm_group>
      <arm_group_label>split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients diagnosed with locally advanced very low rectal cancer were chosen to undergo a total neoadjuvant therapy (TNT) regimen. This regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab.&#xD;
  For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after TNT, an organ-preserving strategy involving local full-thickness resection was implemented. Patients who achieve non-clinical complete response are subjected to traditional TME surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>split-course hypofraction radiotherapy</intervention_name>
      <description>After reaching a cumulative radiotherapy dose of 25Gy in the entire pelvic cavity (PTV1), the treatment field was subsequently narrowed to solely focus on the primary tumor (PTV2), with a total dose of 35Gy administered. All patients will undergo fractionated radiotherapy, following a regimen of 7Gy per fraction, delivered every 3 weeks for five cycles.</description>
      <arm_group_label>split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision</arm_group_label>
      <other_name>hypofraction radiotherapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CAPOX</intervention_name>
      <description>Drug: Oxaliplatin,130mg/m2，ivgtt，d1,for 6 cycles. Drug: Capecitabine,1000mg/m2，po，bid，d1-14, for 6 cycles.</description>
      <arm_group_label>split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision</arm_group_label>
      <other_name>Capecitabine+Oxaliplatin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Envafolimab</intervention_name>
      <description>Envafolimab is administered by subcutaneous injection. The recommended dose is 300 mg per 3 weeks (Q3W) for 6 cycles.</description>
      <arm_group_label>split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision</arm_group_label>
      <other_name>KN035</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Local excision</intervention_name>
      <description>Local full-thickness resection is employed for patients with clinical complete response (cCR) or near-clinical complete response (ncCR) following TNT.</description>
      <arm_group_label>split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 18-75.&#xD;
  &#xD;
            2. Histopathology confirmed the rectal adenocarcinoma,cT3-4N0 or cT1-4N1-2. The tumor's&#xD;
               lower margin ≤ 2cm from the anorectal ring's upper edge (based on MRI measurement).&#xD;
  &#xD;
            3. Eastern tumor cooperation group (ECOG) status:0-2.&#xD;
  &#xD;
            4. American Association of Anesthesiologists (ASA) status: I-III.&#xD;
  &#xD;
            5. No previous systemic therapy, including chemotherapy, immunotherapy, or radiotherapy&#xD;
               for rectal cancer.&#xD;
  &#xD;
            6. No previous history of pelvic radiotherapy.&#xD;
  &#xD;
            7. Sufficient organ function based on the following parameters:&#xD;
  &#xD;
               An absolute neutrophil count≥ 1.5 × 109 / L, a thrombocyte count ≥ 100 × 109/ L, a&#xD;
               glomerular filtration rate (calculated using the Cockcroft-Gault formula) with a&#xD;
               creatinine level ≤ 1.5 × ULN or a creatinine clearance &gt; 50ml/min, and AST and ALT&#xD;
               levels ≤ 2.5 × ULN or a total bilirubin level ≤ 1.5 × ULN.&#xD;
  &#xD;
            8. Effective contraception during the study.&#xD;
  &#xD;
            9. Patients are willing and able to comply with the protocol during the study period.&#xD;
  &#xD;
           10. Patients with written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell&#xD;
               carcinoma, and adenocarcinoma developed from inflammatory bowel disease.&#xD;
  &#xD;
            2. Metastasis to para-aortic, lateral, or inguinal lymph nodes has been identified.&#xD;
  &#xD;
            3. Suspected distant metastasis in organs other than para-aortic, lateral, or inguinal&#xD;
               lymph nodes is being considered.&#xD;
  &#xD;
            4. Known hypersensitivity to platinum drugs or capecitabine.&#xD;
  &#xD;
            5. Patients receiving concomitant treatment with drugs that interact with capecitabine or&#xD;
               oxaliplatin (such as flucytosine, phenytoin, and warfarin).&#xD;
  &#xD;
            6. According to the New York Heart Association (NYHA) classification, III or IV heart&#xD;
               failure, and angina pectoris have occurred in the past six months.&#xD;
  &#xD;
            7. Uncontrolled active infection or severe concomitant systemic disease.&#xD;
  &#xD;
            8. Patients who need immunosuppressive therapy for organ transplantation.&#xD;
  &#xD;
            9. Uncontrolled epilepsy or mental illness.&#xD;
  &#xD;
           10. Pregnant or lactating female patients.&#xD;
  &#xD;
           11. Non-compliance or researchers believe that the patient will not be able to complete&#xD;
               the entire trial&#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_official>
      <last_name>Pan Chi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian Medical University Union Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pan Chi, MD</last_name>
      <phone>+8613675089677</phone>
      <email>cp3169@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jiabin Zheng</last_name>
      <phone>+8613365910080</phone>
      <email>xhyykjk@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pan Chi</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350001</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Pan Chi, MD</last_name>
        <phone>+8613675089677</phone>
        <email>cp3169@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Jiabin Zheng</last_name>
        <phone>+8613365910080</phone>
        <email>xhyykjk@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fujian Medical University Union Hospital</investigator_affiliation>
      <investigator_full_name>池畔</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Locally advanced very low rectal cancer</keyword>
    <keyword>Total neoadjuvant therapy</keyword>
    <keyword>Hypofraction radiotherapy</keyword>
    <keyword>CAPOX</keyword>
    <keyword>Envafolimab</keyword>
    <keyword>Local excision</keyword>
    <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>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05969847
  org study id: 2023XHYG0026-01
  nct id: NCT05969847
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in
        a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of
        preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy
        and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical
        complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local
        full-thickness resection was implemented.
  Locally advanced very low rectal cancer poses significant challenges in rectal cancer
        treatment. Presently, the prevailing approach in clinical practice involves neoadjuvant
        chemoradiotherapy in conjunction with total mesorectal excision (TME). Historically,
        abdominoperineal resection (APR) has been the conventional surgical procedure for managing
        locally advanced very low rectal cancer. However, the long-term presence of a colostomy
        following an abdominoperineal resection (APR) significantly impacts the quality of life for
        patients. Additionally, studies have revealed that 11.8-22% of rectal cancer patients who
        underwent APR after neoadjuvant chemoradiotherapy (nCRT) achieved a pathological complete
        response (pCR). Conversely, 11-52% of patients with pCR after nCRT for rectal cancer
        ultimately underwent APR surgery. Intersphincter resection (ISR) offers a highly beneficial
        surgical approach that preserves the anal sphincter, particularly for individuals with
        locally advanced very low rectal cancer. The patient's postoperative quality of life was
        significantly affected by severe low anterior resection syndrome (LARS), sexual dysfunction,
        and voiding dysfunction.
  
        This study represents an exploratory phase II clinical trial in which patients diagnosed with
        locally advanced very low rectal cancer were chosen to undergo a total neoadjuvant therapy
        (TNT) regimen. This regimen consisted of preoperative fractionated radiotherapy (5×7Gy)
        combined with 6 cycles of CAPOX chemotherapy and enverolimab.
  
        For patients who achieved clinical complete response (cCR) or near-clinical complete response
        (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness
        resection was implemented. Patients who achieve non-clinical complete response are subjected
        to traditional TME surgery.
  
        This study aims to investigate the effectiveness and safety of organ preservation using the
        local resection approach in patients with locally advanced very low rectal cancer. By
        implementing this approach, the study aims to improve the quality of life for patients who
        achieve pathological complete response (pCR), thereby avoiding the need for conventional
        abdominoperineal resection (APR) and intersphincteric resection (ISR) procedures.
        Additionally, this study aims to address the issue of local regrowth associated with the
        "watch & wait" strategy and propose a novel treatment strategy for rectal-sparing surgery in
        patients with locally advanced very low rectal cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Organ preservation
  time frame: 36 months
  description: The rectum is intact, owing to no radical total mesorectal excision (TME), curative (R0) salvage surgery by local excision (LE), and no permanent stoma (including a never reversed protective stoma or a stoma owing to toxicities and/or poor functional outcomes).
  measure: ypT0-1 rate
  time frame: 36 months
  description: The proportion of subjects with primary rectal cancer assessed by hematoxylin and eosin staining including no evidence of primary tumor (T0) or carcinoma in situ: intramucosal carcinoma (invading lamina propria, not infiltrating muscularis mucosa) (Tis) or tumor invading submucosa (T1) (ypT0-1 based on the latest UICC/AJCC staging system)
  measure: Pathological complete response (pCR) rate
  time frame: 36 months
  description: Proportion of subjects with primary rectal cancer and all sampled lymph nodes who did not find any invasive carcinoma and high-grade intraepithelial neoplasia/severe dysplasia after assessment by hematoxylin and eosin staining (Judged as ypT0N0 stage according to the latest UICC/AJCC staging system)
  measure: Acute and late toxicity
  time frame: 36 months
  description: Acute and late toxicity, Incidence of Treatment-Emergent Adverse Events assessment according to NCICTCAE V.5.0
  measure: Local recurrence rate
  time frame: 36months
  description: The proportion of patients in all subjects within 3 years from the start of the surgery to detection of a tumor involving the bowel wall only that occurs after LE or TME
  measure: Local regional recurrence rate
  time frame: 36 months
  description: The proportion of patients in all subjects within 3 years from the start of the surgery to detection of a tumor involving either the bowel wall, mesorectum, and/or pelvic organs that occurs after LE or TME
  measure: Disease-free survival
  time frame: 36 months
  description: The proportion of patients in all subjects within 3 years from the start of the surgery to recurrence, distant metastsis, or death from any cause (whichever occurs first)
  measure: Quality of life-based on EORTC QLQ-C30 and EORTC QLQ-CR29
  time frame: baseline, 3 months, 12 months, 24 months, and 36 months after LE or TME
  description: Quality of life measured using EORTC QLQ-C30 and EORTC QLQ-CR29
  measure: Anorectal function
  time frame: baseline, 3 months, 12 months, 24 months, and 36 months after LE or TME
  description: Anorectal function based on LARS score
  arm group label: split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
  arm group type: Experimental
  description: Patients diagnosed with locally advanced very low rectal cancer were chosen to undergo a total neoadjuvant therapy (TNT) regimen. This regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab.
  For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after TNT, an organ-preserving strategy involving local full-thickness resection was implemented. Patients who achieve non-clinical complete response are subjected to traditional TME surgery.
  intervention type: Radiation
  intervention name: split-course hypofraction radiotherapy
  description: After reaching a cumulative radiotherapy dose of 25Gy in the entire pelvic cavity (PTV1), the treatment field was subsequently narrowed to solely focus on the primary tumor (PTV2), with a total dose of 35Gy administered. All patients will undergo fractionated radiotherapy, following a regimen of 7Gy per fraction, delivered every 3 weeks for five cycles.
  arm group label: split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
  other name: hypofraction radiotherapy
  intervention type: Drug
  intervention name: CAPOX
  description: Drug: Oxaliplatin,130mg/m2，ivgtt，d1,for 6 cycles. Drug: Capecitabine,1000mg/m2，po，bid，d1-14, for 6 cycles.
  arm group label: split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
  other name: Capecitabine+Oxaliplatin
  intervention type: Drug
  intervention name: Envafolimab
  description: Envafolimab is administered by subcutaneous injection. The recommended dose is 300 mg per 3 weeks (Q3W) for 6 cycles.
  arm group label: split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
  other name: KN035
  intervention type: Procedure
  intervention name: Local excision
  description: Local full-thickness resection is employed for patients with clinical complete response (cCR) or near-clinical complete response (ncCR) following TNT.
  arm group label: split-course hypofraction radiotherapy plus CAPOX and Envafolimab followed by local excision
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Pan Chi, MD
  role: Principal Investigator
  affiliation: Fujian Medical University Union Hospital
  last name: Pan Chi, MD
  phone: +8613675089677
  email: cp3169@163.com
  last name: Jiabin Zheng
  phone: +8613365910080
  email: xhyykjk@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fujian Medical University Union Hospital
  investigator full name: 池畔
  investigator title: Professor
  mesh term: Rectal Neoplasms
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  sharing ipd: No