OncoMatch/Clinical Trials/NCT07669220
A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)
Is NCT07669220 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Toripalimab for rectal adenocarcinoma.
Treatment: Toripalimab — This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR/MSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Disease stage
Required: Stage III
Locally advanced disease with high-risk factors, meeting at least one of the following: cT4 / cN2 / EMVI+ / MRF+ / positive lateral lymph node
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1 therapy
History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: radiotherapy
No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
Cannot have received: chemotherapy
No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
Cannot have received: targeted therapy
No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
Cannot have received: immunotherapy
No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
Lab requirements
Blood counts
WBC ≥ 3.0 × 10⁹/L or ANC ≥ 1.5 × 10⁹/L; HGB ≥ 80 g/L; PLT ≥ 100 × 10⁹/L
Kidney function
CREAT < 1.5 × ULN
Liver function
AST/ALT < 3.0 × ULN; TBIL < 1.5 × ULN
Peripheral blood counts and liver and renal function within the following ranges (tested within 15 days before treatment initiation): WBC ≥ 3.0 × 10⁹/L or ANC ≥ 1.5 × 10⁹/L; HGB ≥ 80 g/L; PLT ≥ 100 × 10⁹/L; AST/ALT < 3.0 × ULN; TBIL < 1.5 × ULN; CREAT < 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07669220 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 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage III 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