Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

  • End date
    Oct 18, 2026
  • participants needed
  • sponsor
    Sun Yat-sen University
Updated on 1 March 2022


In this study, participants with locally advanced rectal cancer patients will be treated according to MMR/MSI status. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, dMMR or MSI-H patients will receive neoadjuvant Pd1 antibody Sintilimab and surgery or watch and wait, followed by adjuvant treatment. For Cohort B, pMMR/MSS/MSI-L patients will be randomized to receive neoadjuvant chemoradiotherapy Pd1 antibody Sintilimab followed by surgery or watch and wait, and adjuvant treatment.

Condition Colorectal Cancer Stage II, Colorectal Cancer Stage III, Mmr Deficiency, MSI-H
Treatment Capecitabine, Radiotherapy, Oxaliplatin, Total Mesorectal Excision, Sintilimab, Watch and wait
Clinical Study IdentifierNCT04304209
SponsorSun Yat-sen University
Last Modified on1 March 2022


Yes No Not Sure

Inclusion Criteria

Histologically proven colorectal adenocarcinoma
Cohort 1: Biopsy tissues with IHC indicates deficient mismatch repair(dMMR),that is,the loss of at least one of the four proteins ,MSH1,MSH2,MSH6,PMS2;or gene detection implies MSI-H; Cohort 2: Biopsy tissues with IHC indicates proficient mismatch repair(pMMR),that is positivity of all four proteins ,MSH1,MSH2,MSH6,PMS2;or gene detection implies MSS/MSI-L
Clinical stage for rectal cancer patients is cT3-4N0M0 or cTxN+M0
Preoperative staging methods: all patients need to accept digital rectal examination(DRE).Patients with rectal cancer undergo high-resolution MRIultrasound colonoscopy/transrectal ultrasound for preoperative staging. Perienteric lymph nodes with short diameter 10mm or the shape of lymph nodes and its MRI characteristics are consistent with typical lymph node metastasis. If endoscopic ultrasonography is used in combination, and there is a contradiction between staging methods, the data should be submitted to the evaluation team of our center for the accurate staging
No symptoms of ileus; or ileus is alleviated after proximal colostomy
No rectal surgery except preventative stoma
No chemotherapy or radiotherapy
No biotherapy (e.g.monoclonal antibodies), immunotherapy (e.g.anti-PD-1 antibody,anti-PD-L1 antibody,anti-PD-L2 antibody or CTLA-4 antibody),or other clinical trials agents
No limit to previous endocrine therapy
Age between 18 and 75 years
ECOG performance status of 0 or 1
Life expectancy: more than 2 years
Hematopoietic: WBC>3109/L;PLT>80109/L; Hb>90g/L
Hepatic: ALT and AST<2 times upper limit of normal (ULN); bilirubin<1.5 times ULN
Renal: creatinine <1.5 times ULN or creatinine clearance 60 mL/min

Exclusion Criteria

Arrhythmias require antiarrhythmic therapy (with the exception of -blockers or digoxin), symptomatic coronary artery disease or local myocardial ischemia (myocardial infarction within the past 6 months) or congestive heart failure exceeding NYHA II
Severe hypertension with poor control after medication
A known history of testing positive for HIV or chronic hepatitis B or C (high copy virus DNA) at active stage
Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening
Other active severe clinical infections (NCI-CTC5.0)
Apparent distant metastasis away from the pelvic before surgery
Cachexia, organ function decompensation
Previous pelvic or abdominal radiotherapy
Multiple primary colorectal cancers
Epilepsy require medical treatment (such as steroid or antiepileptic therapy)
Other malignancy within the past 5 years with the exception of effectively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study
Patients have any active autoimmune diseases or a history of autoimmune diseases(including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and decreased thyroid function; patients with vitiligo or with complete remission of asthma in childhood and without any intervention in adulthood may be included; patients with asthma requiring bronchodilators intervention are not included
Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment
Complications require long-term treatment with immunosuppressive drugs, or requiring systemic or local use of immunosuppressive corticosteroids(>10mg/day prednisone or other therapeutic hormones)
Known or suspected allergy to the study drugs or to any drugs related to this trial
Any unstable condition or which endangers the patients' safety and compliance
Pregnant or breast-feeding women who are fertile without effective contraception
Refuse to sign the informed consent
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