OncoMatch/Clinical Trials/NCT06229041
Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)
Is NCT06229041 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: Mismatch-repair deficient (MSI-H / dMMR)
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)
Demographics
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.
Frequently asked questions
Is NCT06229041 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.
Are patients with MSH2 alterations eligible?
No. MSH2 deletion is an exclusion criterion.
Are patients with MSH6 alterations eligible?
No. MSH6 deletion is an exclusion criterion.
What disease stage is eligible?
Stage MRN2 or POSITIVE MRF or POSITIVE EMVI or LATERAL LYMPH NODE METASTASIS (MRLLND+) 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