Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC
Recruiting · NCT07646639 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Metastatic disease (Stage IV).
- Recurrent rectal cancer.
- Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.
- Prior systemic anticancer therapy for 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).
- 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.
- Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
- Pregnant or breastfeeding women.
- 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.
Where it is running
1 location listed.
- Jiangsu Province Hospital - Nanjing, Jiangsu, China