OncoMatch/Clinical Trials/NCT07478731
Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
Is NCT07478731 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies SHR-1701 neoadjuvant for crc (colorectal cancer).
Treatment: SHR-1701 neoadjuvant — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
pMMR or MSS/MSI-L rectal adenocarcinoma
Required: MSI microsatellite stable
pMMR or MSS/MSI-L rectal adenocarcinoma
Required: MSI MSI-L
pMMR or MSS/MSI-L rectal adenocarcinoma
Disease stage
Required: Stage CN2 (clinical TNM)
At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: surgery
Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
Cannot have received: radiotherapy
Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
Cannot have received: chemotherapy
Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
Cannot have received: targeted therapy
Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
Cannot have received: immunotherapy
Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
Lab requirements
Blood counts
Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
Kidney function
Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
Liver function
Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07478731 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
Does this trial require MSI?
Yes, MSI microsatellite stable is a required biomarker for enrollment.
Does this trial require MSI?
Yes, MSI MSI-L is a required biomarker for enrollment.
What disease stage is eligible?
Stage CN2 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages