OncoMatch/Clinical Trials/NCT07070622
Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Is NCT07070622 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
pMMR/MSS by immunohistochemistry and/or genetic testing
Disease stage
Required: Stage CT1-3ABN0-1M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT07070622 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 MLH1?
Yes, MLH1 proficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 proficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 proficient mismatch repair is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT1-3ABN0-1M0 is required.
Is there an age limit?
Yes. Patients must be 80 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