Combination of AK104 and Neoadjuvant Chemoradiotherapy in pMMR/MSS Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer
About this trial
This is an interventional treatment trial for Locally Advanced Rectal Cancer
Eligibility Criteria
Inclusion Criteria: Age 18-75 ECOG 0-1 Rectal adenocarcinoma cT3-4aNany or cT1-4aN+ No distant metastasis Location ≤15 cm from the anal verge the MSI status is MSS and pMMR Sufficient bone marrow, kidney and liver function No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy, no immunotherapy Exclusion Criteria: bowel obstruction Distant metastasis Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV ) Uncontrollable severe hypertesion Active severe infection Cachexia, organ dysfunction Previous pelvic radiotherapy or chemotherapy Multiple primary cancers Epileptic seizures Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma Persons deprived of liberty or under guardianship Impossibility for compliance to follow-up Certain or suspicious allergy to research drug Pregnant or breast-feeding woman
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Treatment Arm
A total of 33 pMMR/MSS LARC patients will receive long-course chemoradiotherapy plus 2 cycles of AK104, followed by another 3 cycles of AK104, finally received clinical routine manage.