NCT07646639RecruitingPhase 2
Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC
Different-Dose Short-Course Radiotherapy Plus CAPOX, Anti-PD-1 Antibody and Interleukin-2 for Locally Advanced Rectal Cancer: A Single-Centre, Prospective, Randomised Phase II Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 20 May 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT07646639
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 122
- From 20 May 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.
- Prior systemic anticancer therapy for rectal cancer.
- Any unresolved grade \>=2 toxicity (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) resulting from previous treatment, except for anemia, alopecia, and skin hyperpigmentation.
Other illness
- Metastatic disease (Stage IV).
- Recurrent rectal cancer.
- Presence of another non-colorectal neoplastic disease at the same time.
- Patients with any active autoimmune disease or a history of autoimmune disease requiring steroids or immunomodulatory therapy.
- Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonitis).
- Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Known or suspected history of allergy to any of the relevant drugs used in the study.
Lab values
- Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Male and female patients aged 18 to 70 years.
- Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge.
- MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.