PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer

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Brief Title

PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer

Official Title

PD-1 Antibody as a Sequential Therapy Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer: an Open, Multi-center, Phase II Clinical Trial

Brief Summary

      In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with
      PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal
      cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be
      given during the window period until surgical resection of the tumor.

Study Phase

Phase 2

Study Type


Primary Outcome

Pathological complete response

Secondary Outcome

 Relapse-free survival (RFS)


Lynch Syndrome


PD-1 antibody

Study Arms / Comparison Groups

 PD-1 antibody + capecitabine + radiation


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

January 1, 2021

Completion Date

December 31, 2026

Primary Completion Date

December 31, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who personally provided written consent for participation in the study

          -  Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor
             was at a distance of 12 cm or less from the AV before CRT

          -  Primary rectal cancer histopathologically confirmed to be adenocarcinoma

          -  Clinical stage of T3,and T4 ,N any,M0,before CRT

          -  Macroscopic radical resection could be feasible, based on diagnostic imaging before

          -  Patients with the ECOG performance status of 0 or 1 at the time of enrollment

          -  Patients without distant metastasis on the imaging test before CRT

          -  Preoperative biopsy of tumor immunohistochemistry TPS>1% or CPS>1

          -  Life expectancy of greater than 2 years

          -  No signs of intestinal obstruction; or the obstruction has been relieved after the
             proximal colostomy operation

          -  Hematology: WBC>4000/mm3; PLT>100000/mm3; Hb>10g/dL

          -  Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is
             less than 1.5mg/dL

          -  Renal function: creatinine <1.8mg/dL Others: non-pregnant or breast-feeding women; no
             other malignant diseases (except for non-melanoma or cervical carcinoma in situ)
             within 5 years or during the same period; no mental illness that causes the inability
             to obtain informed consent; no other serious diseases that can shorten the survival
             time disease.

          -  Have not received rectal surgery in the past;

          -  Have not received chemotherapy or radiotherapy in the past;

          -  Have not received biological treatment in the past;

          -  Past endocrine therapy: unlimited.

        Exclusion Criteria:

          -  Rectal cancer with unstable microsatellite (MSI or dMMR);

          -  Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1

          -  Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high
             copy viral DNA);

          -  Autoimmune diseases;

          -  Other active clinical serious infections (>NCI-CTC version 3.0);

          -  Patients in clinical phase I;

          -  There is evidence that there is distant metastasis before surgery;

          -  Cachexia, decompensation of organ function;

          -  Have a history of pelvic or abdominal radiotherapy;

          -  Multiple primary cancers;

          -  Patients who need treatment for seizures (such as steroids or anti-epileptic

          -  Have a known additional malignant tumors within 5 years. Exceptions include basal cell
             carcinoma of the skin that has undergone potentially curative therapy or in situ
             cervical cancer;

          -  Chronic inflammatory bowel disease, intestinal obstruction;

          -  Drug abuse and medical, psychological or social conditions may interfere with
             patients' participation in research or have an impact on the evaluation of research

          -  Known or suspected to be allergic to the study drug or to any drug given in connection
             with this test;

          -  Any unstable conditions or situations that may endanger patient safety and compliance




18 Years - 75 Years

Accepts Healthy Volunteers



, 13543478645 Ext. +86, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


 Liaoning Tumor Hospital & Institute

Study Sponsor

, , 

Verification Date

April 2021