A Phase II, Prospective, Single Arm Study of Neoadjuvant SHR-1701 Combine With Chemoradiotherapy for Locally Advanced Rectal Cancer
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC. Participants will take: Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
• 1: Sign the informed consent form and voluntarily participate in this study
• 2: Age 18-75
• 3: Pathologically confirmed rectal adenocarcinoma（At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+）
• 4: pMMR or MSS/MSI-L rectal adenocarcinoma
• 5: The distance from tumor edge to the anal verge
• 6: Expect to complete R0 resection
• 7: Patients can swallow pills
• 8: ECOG PS 0-1
• 9: Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
• 10: Plan to complete surgery after neoadjuvant therapy
• 11: There is contraindication to surgery
• 12: Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
• 13: Female subjects with reproductive capacity are required to undergo a serum pregnancy test 72 hours before starting the administration of the test drug, and the result must be negative. During the trial period and for at least 3 months after the last administration, they must take effective contraceptive measures (such as intrauterine devices, contraceptives, or condoms). For male subjects whose partners are female with reproductive capacity, effective contraceptive measures must be taken during the trial period and for at least 3 months after the last administration.