OncoMatch/Clinical Trials/NCT07646639
Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC
Is NCT07646639 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Sintilimab + IL-2 Combined with CAPOX for rectal cancer.
Treatment: Sintilimab + IL-2 Combined with CAPOX — This prospective, randomized phase II trial is designed to evaluate whether low-dose short-course radiotherapy differs from common-dose short-course radiotherapy in terms of efficacy when both regimens are sequentially combined with CAPOX, a PD-1 monoclonal antibody, and interleukin-2 (IL-2) in patients with locally advanced rectal cancer. The study is based on findings from our previous single-center, single-arm PRIDE01 study, in which neoadjuvant short-course radiotherapy followed by systemic chemoimmunotherapy and IL-2 demonstrated encouraging antitumor activity relative to historical short-course radiotherapy-based approaches. The current trial aims to provide more robust clinical evidence regarding the potential role of low-dose radiotherapy combined with IL-2 as a sensitization strategy in multimodal neoadjuvant therapy. By comparing complete response rates between the two radiotherapy dose levels, this study may help define an optimized neoadjuvant approach and support future organ-preservation strategies for patients with locally advanced rectal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage ANY T WITH N+ (other)
Excluded: Stage IV
MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease. Metastatic disease (Stage IV) [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
Demographics
Prior therapy
Cannot have received: systemic anticancer therapy for rectal cancer
Prior systemic anticancer therapy for rectal cancer
Cannot have received: anti-PD-1/PD-L1 antibody
Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody
Cannot have received: anti-CTLA-4 antibody
Prior treatment with anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Lab requirements
Blood counts
absolute neutrophil count >=1.5 x 10^9/L; platelet count >=75 x 10^9/L
Kidney function
serum creatinine <=1.5 x UNL
Liver function
serum total bilirubin <=1.5 x upper normal limit (UNL); aspartate aminotransferase <=2.5 x UNL; alanine aminotransferase <=2.5 x UNL
Adequate hematologic, hepatic, and renal function defined as: absolute neutrophil count >=1.5 x 10^9/L; platelet count >=75 x 10^9/L; serum total bilirubin <=1.5 x upper normal limit (UNL); aspartate aminotransferase <=2.5 x UNL; alanine aminotransferase <=2.5 x UNL; serum creatinine <=1.5 x UNL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07646639 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.
What disease stage is eligible?
Stage ANY T WITH N+ is required.
Is there an age limit?
Yes. Patients must be 70 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