Status:
ACTIVE_NOT_RECRUITING
Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colorectal Cancer Stage II
Colorectal Cancer Stage III
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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 MRI±ultrasound 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\>3×109/L;PLT\>80×109/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
- Arrhythmias require antiarrhythmic therapy (with the exception of β-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.
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2026
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04304209
Start Date
October 28 2019
End Date
October 18 2026
Last Update
February 1 2023
Active Locations (1)
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1
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060