๐ฌIn plain words
What the trial is, and whether it could suit you
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 radiothe
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Male and female patients aged 18 to 70 years.
2. Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge.
3. MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Exclusion Criteria:
1. Metastatic disease (Stage IV).
2. Recurrent rectal cancer.
3. Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.
4. Prior systemic anticancer therapy for rectal cancer.
5. Presence of another non-colorectal neoplastic disease at the same time.
6. Patients with any active autoimmune disease or a history of autoimmune disease requiring steroids or immunomodulatory therapy.
7. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonitis).
8. 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.
9. Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
10. Pregnant or breastfeeding women.
11. Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
12. Known or suspected history of allergy to any of the relevant drugs used in the study.
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What it tests
- Sintilimab + IL-2 Combined with CAPOX
- Short-course low-dose radiotherapy
- Short-course standard-dose radiotherapy
Jiangsu Province Hospital
Nanjing, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.