NCT06108596CompletedPhase 2
Evaluation of the Efficacy and Safety of Interleucin-2 Combined With PD-1 Monoclonal Antibody and CAPOX in Preoperative Neoadjuvant Therapy for Mid-low Locally Advanced Rectal Cancer - a Single-center, Single-arm, Open-label Clinical Trail
Evaluation of the Efficacy and Safety of Interleucin-2 Combined With PD-1 Monoclonal Antibody and CAPOX in Preoperative Neoadjuvant Therapy for Mid-low Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov · Last updated 21 Jan 2025
Brief summary (registry, in English)
Evaluation of the efficacy and safety of interleucin-2 combined with PD-1 monoclonal antibody and CAPOX in preoperative neoadjuvant therapy for mid-lower locally advanced rectal cancer - a single-center, single-arm, open-label clinical trail.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 25 Oct 2023
- Start date
- 21 Oct 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT06108596
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 33
- From 21 Oct 2023 to the primary completion date, 31 Dec 2024
- 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
- Metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent presence of other non-colorectal malignancies;
- Patients who have previously received systemic anticancer therapy for colorectal cancer; or patients treated with PD-1, PD-L1, or CTLA-4 antibodies;
- Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history of treatment with steroids or immunosuppressive drugs;
- Patients who experienced any Grade 2 or higher toxicity due to previous treatments (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5), which has not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected allergy to any of the related drugs used in the trial;
Other illness
- Rectal or colon cancer located more than 12 cm from the anal verge;
- Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Males and females aged between 18 and 75 years;
- ECOG performance status score of 0 or 1;
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage T3-T4 or any T with positive lymph nodes (N+): locally advanced;
- Microsatellite stable (MSS) or deficient mismatch repair (dMMR) status;
- Distance from the anal verge ≤ 12 cm;
- Adequate hematologic, hepatic, and renal function.
Age in the registry: 18 years to 75 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 | Unknown status |
Related publications
- Total neoadjuvant chemotherapy combined with PD‑1 blockade and IL‑2 in MSS/pMMR locally advanced rectal cancer: short-term results of a prospective, single-arm phase II study.Signal Transduct Target Ther · 2026 · PMID 42071008
This page is information, not medical advice. Discuss any trial with your doctor.