Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer

NCT06504875 | Not Yet Recruiting DMC

• 1 other identifier: PICTURE202407
• Study Type: observational
• Target: 23
• Locations: 0 countries
• Sites: N/A

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) and organ preservation rate in patients with MSS/pMMR locally advanced rectal cancer.

Conditions

Rectal Cancer

Keywords

Tislelizumab; Interleukin-2; MSS/pMMR rectal cancer

Outcome Measures

Primary Outcomes (1)

• CR rate (cCR + local excision pCR)

  Complete Response rate," which includes both "complete clinical response" (cCR) and "pathologic complete response after local excision" (pCR)

  1 years

Secondary Outcomes (3)

• organ preservation rates

  1 month

• Event-Free Survival rates

  5 years

• Overall Survival rates

  5 year

Study Arms (1)

CapeOX+PD-1+IL-2

Tislelizumab 200mg ivd D1 + Interleukin 2 100IU HD,QOD d1-d14 +CapeOX (Capecitabine: 1000mg/m2 bid po, d1-d14；Oxaliplatin 130mg/m2 ivd, d1) 6 cycles

Drug: Tislelizumab; Drug: Interleukin-2; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Tislelizumab DRUG

Tislelizumab 200mg ivd D1

CapeOX+PD-1+IL-2

Interleukin-2 DRUG

Interleukin 2 100IU HD,QOD d1-d14

CapeOX+PD-1+IL-2

Capecitabine DRUG

Capecitabine: 1000mg/m2 bid po, d1-d14

CapeOX+PD-1+IL-2

Oxaliplatin DRUG

Oxaliplatin 130mg/m2 ivd, d1

CapeOX+PD-1+IL-2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Age ≥18 years and ≤75 years 2. Histologically confirmed adenocarcinoma of the rectum 3. pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable) 4. Tumor distance from the anal verge ≤5 cm 5. Clinical stage of cT1-3N1M0 or cT2-3N0M0 6. ECOG performance status score ≤ 1

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

tislelizumab; Interleukin-2; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Yueming Sun

CONTACT

862568306026; sunyueming@njmu.edu.cn

Yue Wang, MD

CONTACT

862568306026; wangyue@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 10, 2024
• Primary Completion: July 10, 2025
• Study Completion (Estimated): July 10, 2027
• Last Updated: July 17, 2024

Record last verified: 2024-07