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/NCT06002789</url>
    </required_header>
    <id_info>
      <org_study_id>E2023073</org_study_id>
      <nct_id>NCT06002789</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC</brief_title>
    <official_title>Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair/Microsatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sixth Affiliated Hospital, Sun Yat-sen 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>
        At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer&#xD;
        is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1&#xD;
        monoclonal antibody has a significant effect in the second-line/first-line treatment of&#xD;
        dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal&#xD;
        cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of&#xD;
        colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent&#xD;
        primary malignancies in the colon or rectum. The recent large-scale, single-center&#xD;
        retrospective study of the investigator showed that compared with single primary colorectal&#xD;
        cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC&#xD;
        patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors&#xD;
        at the same time. There is no standard regimen for this patients so far. This study intends&#xD;
        to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1&#xD;
        monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with&#xD;
        single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the&#xD;
        guideline, the investigator intends to take the lead in carrying out this open, multi-center,&#xD;
        prospective clinical phase II study. This study might provide a clinical evidence for&#xD;
        individual treatment of sMPCC patients, in preserving the functions and organs to the&#xD;
        greatest extent.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Colorectal cancer is one of the most common malignant tumors in the world. At present,&#xD;
        radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the&#xD;
        standard comprehensive treatment recommended by the two major international guidelines of&#xD;
        NCCN and ESMO, as well as the Chinese CSCO guidelines. Mismatch repair protein (MMR)&#xD;
        expression and microsatellite instability (MSI) status are important factors affecting the&#xD;
        efficacy of immunotherapy. In recent years, immunotherapy of PD-1 monoclonal antibody has a&#xD;
        significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal&#xD;
        cancer and the neoadjuvant treatment of early colorectal cancer, all of which have shown very&#xD;
        good efficacy with great safety and tolerable toxicity.&#xD;
  &#xD;
        Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of&#xD;
        colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent&#xD;
        primary malignancies in the colon or rectum of the same patient. Since 2000, the annual&#xD;
        incidence and mortality of CRC in China have continued to increase, and the incidence of&#xD;
        sMPCC has also increased. The overall incidence of sMPCC ranges from 1.1% to 8.1% of CRC&#xD;
        patients. The recent large-scale, single-center retrospective study of the investigator&#xD;
        showed that among 239 sMPCC patients, the proportions of all-pMMR, all-dMMR, and mixed types&#xD;
        (pMMR/dMMR) were 189 (79.1%), 40 (16.7%), and 10 (4.2%), respectively. Compared with single&#xD;
        primary colorectal cancer (SPCRC) patients, the incidence of dMMR was significantly higher in&#xD;
        sMPCC patients (50/239 vs 872/13037). The results of NGS detection of MSI status were&#xD;
        consistent with the results of Immunohistochemistry (IHC), 21.8% (17/78) of sMPCC patients&#xD;
        were MSI-H, while the proportion was only 5.3% (5/94) in SPCRC patients. At present,&#xD;
        single-drug PD-1 or combined with other immunotherapy has become the first-line treatment for&#xD;
        MSI-H SPCRC patients. However, there is no standard regimen for some sMPCC patients who both&#xD;
        have MSI-H and MSS lesions. Moreover, there are no studies and reports on the treatment of&#xD;
        mFOLFOX6+PD-1 monoclonal antibody in MSI-H/MSS mixed sMPCC and PD-1 monoclonal antibody in&#xD;
        all-MSI-H sMPCC.&#xD;
  &#xD;
        This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination&#xD;
        of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR)&#xD;
        sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. As one of the&#xD;
        largest single centers for the diagnosis and treatment of colorectal cancer in China, the&#xD;
        Sixth Affiliated Hospital of Sun Yat-sen University has performed nearly 4,000 cases of&#xD;
        colorectal cancer surgery per year. Therefore, the investigator intends to take the lead in&#xD;
        carrying out this open, multi-center, prospective clinical phase II study in the world. The&#xD;
        investigator will give different treatments by the result of microsatellite instability&#xD;
        status of all lesions in sMPCC. The pCR rate, incidence of AEs of neoadjuvant therapy, R0&#xD;
        resection rate, down-stage rate, 3 years DFS rate and OS rate are analyzed. This study might&#xD;
        provide a clinical evidence for individual treatment of sMPCC patients, in preserving the&#xD;
        functions and organs to the greatest extent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>
      <intervention_model_description>MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pCR rate</measure>
      <time_frame>1 year</time_frame>
      <description>pathological complete remission rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events</measure>
      <time_frame>1 year</time_frame>
      <description>Incidence rate of participants with Grade ≥3 PD-1monoclonal antibody-related adverse events as assessed by CTCAE v4.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence rate of Grade ≥3 chemotherapy-related adverse events</measure>
      <time_frame>1 year</time_frame>
      <description>Incidence rate of participants with Grade ≥3 chemotherapy-related adverse adverse events as assessed by CTCAE v4.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>R0 resection rate</measure>
      <time_frame>1 year</time_frame>
      <description>R0 resection rate in participants treated after mFOLFOX6+Bevacizumab+PD-1monoclonal antibody</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Down-stage rate</measure>
      <time_frame>1 year</time_frame>
      <description>Down-stage rate of pathological stage after surgery compared with clinical stage before drug treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 years DFS Rate</measure>
      <time_frame>3 years</time_frame>
      <description>3 years Disease Free Survival Rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 years OS Rate</measure>
      <time_frame>3 years</time_frame>
      <description>3 years Overall Survival Rate</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">17</enrollment>
    <condition>Multiple Cancer</condition>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>MSI-H/MSS (dMMR/pMMR) mixed sMPCC: Synchronous multiple primary colorectal cancer consist of MSI/dMMR and MSS/pMMR tumors at the same time&#xD;
  all-MSI-H (dMMR) sMPCC: Synchronous multiple primary colorectal cancer with all MSI/dMMR tumors</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy</intervention_name>
      <description>For MSI-H/MSS (dMMR/pMMR) mixed sMPCC, a combination of neoadjuvant chemotherapy with mFOLFOX6 and immunotherapy with PD-1 monoclonal antibody are applied.</description>
      <arm_group_label>MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC</arm_group_label>
      <other_name>Mixed sMPCC</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy</intervention_name>
      <description>For all-MSI-H (dMMR) sMPCC, single-drug PD-1 monoclonal antibody immunotherapy is applied.</description>
      <arm_group_label>MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC</arm_group_label>
      <other_name>MSI-H sMPCC</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);&#xD;
  &#xD;
            2. Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR,&#xD;
               including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and&#xD;
               PMS2; or at least one tumor lesion identified MSI-H by polymerase chain reaction or&#xD;
               next-generation sequencing technique;&#xD;
  &#xD;
            3. Clinical staging T3-4NxM0, with or without positive MRF, with or without positive&#xD;
               EMVI;&#xD;
  &#xD;
            4. Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal&#xD;
               palpation, high resolution MRI examination，positive perienteric lymph node(LN): short&#xD;
               diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data&#xD;
               should be re-evaluated and judged by center evaluation group when there are&#xD;
               contradictory stagings，distant metastasis were excluded by chest and abdominal&#xD;
               enhanced CT and pelvic enhanced MRI;&#xD;
  &#xD;
            5. No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;&#xD;
  &#xD;
            6. No colorectal surgery history;&#xD;
  &#xD;
            7. No chemotherapy or radiotherapy history;&#xD;
  &#xD;
            8. No biopharmaceutical treatment history(such as monoclonal antibody),&#xD;
               immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or&#xD;
               anti CTLA-4), or other research drug treatment;&#xD;
  &#xD;
            9. No endocrinotherapy history restriction;&#xD;
  &#xD;
           10. informed consent assigned.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin),&#xD;
               symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within&#xD;
               6 months) or congestive heart-failure (CHF) &gt; NYHA grade II;&#xD;
  &#xD;
            2. Severe hypertension not well controlled by drugs;&#xD;
  &#xD;
            3. HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus&#xD;
               DNA);&#xD;
  &#xD;
            4. Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1&#xD;
               year before trial screen;&#xD;
  &#xD;
            5. Other active clinical severe infection(NCI-CTC AE V5.0);&#xD;
  &#xD;
            6. Outside pelvic distant metastasis evidences;&#xD;
  &#xD;
            7. Dyscrasia, organ dysfunction;&#xD;
  &#xD;
            8. Pelvic or abdominal radiotherapy history;&#xD;
  &#xD;
            9. Epilepsy need treatments(Steroid or anti-epilepsy therapy);&#xD;
  &#xD;
           10. Other malignant tumor history within 5 years;&#xD;
  &#xD;
           11. Over abuse of drugs, medical and psychological or social conditions that might&#xD;
               interfere patients or evaluation of the study results;&#xD;
  &#xD;
           12. Any active autoimmune disease or autoimmune disease history (including but not&#xD;
               restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,&#xD;
               nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators);&#xD;
  &#xD;
           13. Any anti-infection vaccine injection 4 weeks before inclusion;&#xD;
  &#xD;
           14. Long-term exposure to immune-suppressor, combination of systemic or topical use of&#xD;
               corticosteroids (dose&gt;10mg/day prednisolone or equivalent hormone);&#xD;
  &#xD;
           15. Known or suspicious allergy to any study related drugs;&#xD;
  &#xD;
           16. Any unstable state might cause damage to the safety and compliance of patients;&#xD;
  &#xD;
           17. Pregnant or breast feeding women who has ability to have children while without&#xD;
               contraception;&#xD;
  &#xD;
           18. Refuse to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Synchronous multiple primary colorectal cancer</keyword>
    <keyword>PD-1</keyword>
    <keyword>Neoadjuvant treatment</keyword>
    <keyword>MSI-H</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
      <mesh_term>Antibodies</mesh_term>
      <mesh_term>Immunoglobulins</mesh_term>
      <mesh_term>Antibodies, Monoclonal</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/NCT06002789
  org study id: E2023073
  nct id: NCT06002789
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer
        is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1
        monoclonal antibody has a significant effect in the second-line/first-line treatment of
        dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal
        cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of
        colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent
        primary malignancies in the colon or rectum. The recent large-scale, single-center
        retrospective study of the investigator showed that compared with single primary colorectal
        cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC
        patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors
        at the same time. There is no standard regimen for this patients so far. This study intends
        to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1
        monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with
        single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the
        guideline, the investigator intends to take the lead in carrying out this open, multi-center,
        prospective clinical phase II study. This study might provide a clinical evidence for
        individual treatment of sMPCC patients, in preserving the functions and organs to the
        greatest extent.
  Colorectal cancer is one of the most common malignant tumors in the world. At present,
        radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the
        standard comprehensive treatment recommended by the two major international guidelines of
        NCCN and ESMO, as well as the Chinese CSCO guidelines. Mismatch repair protein (MMR)
        expression and microsatellite instability (MSI) status are important factors affecting the
        efficacy of immunotherapy. In recent years, immunotherapy of PD-1 monoclonal antibody has a
        significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal
        cancer and the neoadjuvant treatment of early colorectal cancer, all of which have shown very
        good efficacy with great safety and tolerable toxicity.
  
        Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of
        colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent
        primary malignancies in the colon or rectum of the same patient. Since 2000, the annual
        incidence and mortality of CRC in China have continued to increase, and the incidence of
        sMPCC has also increased. The overall incidence of sMPCC ranges from 1.1% to 8.1% of CRC
        patients. The recent large-scale, single-center retrospective study of the investigator
        showed that among 239 sMPCC patients, the proportions of all-pMMR, all-dMMR, and mixed types
        (pMMR/dMMR) were 189 (79.1%), 40 (16.7%), and 10 (4.2%), respectively. Compared with single
        primary colorectal cancer (SPCRC) patients, the incidence of dMMR was significantly higher in
        sMPCC patients (50/239 vs 872/13037). The results of NGS detection of MSI status were
        consistent with the results of Immunohistochemistry (IHC), 21.8% (17/78) of sMPCC patients
        were MSI-H, while the proportion was only 5.3% (5/94) in SPCRC patients. At present,
        single-drug PD-1 or combined with other immunotherapy has become the first-line treatment for
        MSI-H SPCRC patients. However, there is no standard regimen for some sMPCC patients who both
        have MSI-H and MSS lesions. Moreover, there are no studies and reports on the treatment of
        mFOLFOX6+PD-1 monoclonal antibody in MSI-H/MSS mixed sMPCC and PD-1 monoclonal antibody in
        all-MSI-H sMPCC.
  
        This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination
        of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR)
        sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. As one of the
        largest single centers for the diagnosis and treatment of colorectal cancer in China, the
        Sixth Affiliated Hospital of Sun Yat-sen University has performed nearly 4,000 cases of
        colorectal cancer surgery per year. Therefore, the investigator intends to take the lead in
        carrying out this open, multi-center, prospective clinical phase II study in the world. The
        investigator will give different treatments by the result of microsatellite instability
        status of all lesions in sMPCC. The pCR rate, incidence of AEs of neoadjuvant therapy, R0
        resection rate, down-stage rate, 3 years DFS rate and OS rate are analyzed. This study might
        provide a clinical evidence for individual treatment of sMPCC patients, in preserving the
        functions and organs to the greatest extent.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC
  primary purpose: Treatment
  masking: None (Open Label)
  measure: pCR rate
  time frame: 1 year
  description: pathological complete remission rate
  measure: Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events
  time frame: 1 year
  description: Incidence rate of participants with Grade ≥3 PD-1monoclonal antibody-related adverse events as assessed by CTCAE v4.0
  measure: Incidence rate of Grade ≥3 chemotherapy-related adverse events
  time frame: 1 year
  description: Incidence rate of participants with Grade ≥3 chemotherapy-related adverse adverse events as assessed by CTCAE v4.0
  measure: R0 resection rate
  time frame: 1 year
  description: R0 resection rate in participants treated after mFOLFOX6+Bevacizumab+PD-1monoclonal antibody
  measure: Down-stage rate
  time frame: 1 year
  description: Down-stage rate of pathological stage after surgery compared with clinical stage before drug treatment
  measure: 3 years DFS Rate
  time frame: 3 years
  description: 3 years Disease Free Survival Rate
  measure: 3 years OS Rate
  time frame: 3 years
  description: 3 years Overall Survival Rate
  arm group label: MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC
  arm group type: Experimental
  description: MSI-H/MSS (dMMR/pMMR) mixed sMPCC: Synchronous multiple primary colorectal cancer consist of MSI/dMMR and MSS/pMMR tumors at the same time
  all-MSI-H (dMMR) sMPCC: Synchronous multiple primary colorectal cancer with all MSI/dMMR tumors
  intervention type: Drug
  intervention name: MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy
  description: For MSI-H/MSS (dMMR/pMMR) mixed sMPCC, a combination of neoadjuvant chemotherapy with mFOLFOX6 and immunotherapy with PD-1 monoclonal antibody are applied.
  arm group label: MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC
  other name: Mixed sMPCC
  intervention type: Drug
  intervention name: All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy
  description: For all-MSI-H (dMMR) sMPCC, single-drug PD-1 monoclonal antibody immunotherapy is applied.
  arm group label: MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC
  other name: MSI-H sMPCC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  mesh term: Antineoplastic Agents, Immunological
  mesh term: Antibodies
  mesh term: Immunoglobulins
  mesh term: Antibodies, Monoclonal