Status:
NOT_YET_RECRUITING
Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
The objective is to evaluate whether the neoadjuvant combination of PD-1 inhibitor tislelizumab and interleukin-2 (IL-2) can significantly enhance the complete response rate (cCR + local excision pCR)...
Detailed Description
Colorectal cancer (CRC) stands as a prominent global health concern, ranking among the most prevalent malignancies worldwide. Its incidence exhibits striking geographical variations, with higher rates...
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤75 years
- Histologically confirmed adenocarcinoma of the rectum
- pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable)
- Tumor distance from the anal verge ≤5 cm
- Clinical stage of cT1-3N1M0 or cT2-3N0M0
- ECOG performance status score ≤ 1
Exclusion
- Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
- Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been 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 requiring steroid or immunosuppressive drug treatment.
- Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
- Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 10 2027
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06504875
Start Date
July 10 2024
End Date
July 10 2027
Last Update
July 17 2024
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