OncoMatch/Clinical Trials/NCT07070622
Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Is NCT07070622 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies patients were assigned to receive TNT or iTNT management for rectal cancer.
Treatment: patients were assigned to receive TNT or iTNT management — On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of the rectum (the long diameter of the tumor was shortened by ≥30% compared with that before treatment) were randomly divided into two groups. One group was long-course chemoradiotherapy combined with consolidation chemotherapy (TNT group). In the other group, long-term chemoradiotherapy combined with immunotherapy and consolidation chemotherapy (iTNT group), we explored whether TNT could achieve a higher organ preservation rate after effective neoadjuvant chemotherapy in patients with low and intermediate-risk low rectal cancer, and the organ preservation rate of TNT combined with immunotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 proficient mismatch repair
pMMR/MSS by immunohistochemistry and/or genetic testing
Required: MSH2 proficient mismatch repair
pMMR/MSS by immunohistochemistry and/or genetic testing
Required: MSH6 proficient mismatch repair
pMMR/MSS by immunohistochemistry and/or genetic testing
Required: PMS2 proficient mismatch repair
pMMR/MSS by immunohistochemistry and/or genetic testing
Disease stage
Required: Stage CT1-3ABN0-1M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment
Cannot have received: radiotherapy
did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment
Cannot have received: surgery
did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment
Cannot have received: targeted therapy
have received or are receiving any of the following therapies: targeted therapy
Cannot have received: anti-PD-1 therapy
have received or are receiving any of the following therapies: Anti-pd-1 or anti-PD-L1 antibody therapy
Cannot have received: anti-PD-L1 therapy
have received or are receiving any of the following therapies: Anti-pd-1 or anti-PD-L1 antibody therapy
Cannot have received: study drug
received any study drug within 4 weeks before the first dose of the study drug
Cannot have received: chemotherapy
have received or are receiving any of the following therapies: chemotherapy
Cannot have received: radiotherapy
have received or are receiving any of the following therapies: radiotherapy
Lab requirements
Blood counts
HB ≥9g/dL, WBC ≥ 3.5/4.0×10^9/L, neutrophil ≥ 1.5×10^9/L, PLT≥ 100×10^9/L
Kidney function
Crea ≤ 1.0 times ULN
Liver function
Crea and BIL ≤ 1.0 times ULN, ALT and AST ≤ 2.5 times ULN, ALP ≤ 2.5×ULN, total bilirubin ≤ 1.5×ULN
Normal main organ function, which met the following characteristics: ① Blood routine examination criteria: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophil ≥ 1.5×109/L, PLT≥ 100×109/L; ② Biochemical examination should meet the following criteria: Crea and BIL ≤ 1.0 times the upper limit of normal value (ULN), ALT and AST≤ 2.5 times the upper limit of normal value (ULN), alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (Tbil) ≤1.5×UNL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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