OncoMatch/Clinical Trials/NCT06229041
Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)
Is NCT06229041 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Camrelizumab ＋Immunotherapy for rectal cancer.
Treatment: Camrelizumab ＋Immunotherapy — The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MSH2 deletion
mismatch repair gene deletion (dMMR)
Excluded: MSH6 deletion
mismatch repair gene deletion (dMMR)
Excluded: MLH1 deletion
mismatch repair gene deletion (dMMR)
Excluded: PMS2 deletion
mismatch repair gene deletion (dMMR)
Disease stage
Required: Stage MRN2, POSITIVE MRF, POSITIVE EMVI, LATERAL LYMPH NODE METASTASIS (MRLLND+) (MRI-based and TNM)
The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: pelvic radiotherapy
No history of pelvic radiotherapy
Cannot have received: chemotherapy
No history of rectal cancer surgery or chemotherapy
Cannot have received: anti-PD-1 therapy
Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
Cannot have received: anti-PD-L1 therapy
Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
Cannot have received: anti-PD-L2 therapy
Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
Cannot have received: VEGFR inhibitor
Patients who have previously received ... VEGFR TKI therapy
Cannot have received: other anti-tumor or experimental therapy
Have received other types of anti-tumor or experimental therapy
Lab requirements
Blood counts
ANC>1.5 cells/mm3, HGB>9.0g/dL, PLT>800,000/mm3
Kidney function
Serum creatinine ≤1.5 times the upper limit of normal and endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
Liver function
total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN
Cardiac function
Normal cardiac function, normal or abnormal ECG has no clinical significance, LVEF >50%
Blood routine: ANC>1.5 cells/mm3, HGB>9.0g/dL, PLT>800,000/mm3; Blood biochemistry: total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN; Serum creatinine ≤1.5 times the upper limit of normal and endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula); Normal cardiac function, that is, normal or abnormal ECG examination has no clinical significance, and left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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