NCT06504875Not 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
Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer: A Single-center, Single-arm, Open-label Clinical Study (PICTURE)
Source: ClinicalTrials.gov · Last updated 17 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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) and organ preservation rate in patients with MSS/pMMR locally advanced rectal cancer.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 23 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- 10 Jul 2024
- Primary completion date
- 10 Jul 2025
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT06504875
What you commit to
- Study type: Observational
- Planned participants: 23
- From 10 Jul 2024 to the primary completion date, 10 Jul 2025
- No sites listed in no 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
- 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 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.
Other illness
- 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).
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.