A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy With IL-2 Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer

NCT06577194 | Recruiting Phase 2

• 1 other identifier: PRSYM20240827
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy with IL-2 Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer

Conditions

Rectal Cancer; Advanced Solid Tumor

Keywords

Immunotherapy; Short-course radiotherapy; IL-2

Outcome Measures

Primary Outcomes (1)

• Complete remission

  The rate of pathological complete remission (pCR) plus clinical complete remission (cCR).

  Two years

Study Arms (1)

Experimental group

EXPERIMENTAL

Experimental arm

Drug: Sintilimab + IL-2 Combined with CAPOX; Radiation: Short-course radiotherapy

Interventions

Sintilimab + IL-2 Combined with CAPOX DRUG

Sintilimab + IL-2 Combined with Capox

Experimental group

Short-course radiotherapy RADIATION

Short-course radiotherapy+IL-2

Experimental group

Eligibility Criteria

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

You may qualify if:

• Males and females aged between 18 and 70 years;
• ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
• Tumor tissue samples obtained and histologically confirmed as rectal adenocarcinoma;
• Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10\^9/L; platelet count ≥ 75×10\^9/L; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL.

You may not qualify if:

• Metastatic disease (Stage IV);
• Recurrent rectal cancer;
• Concurrent active bleeding, perforation, or other complex situations that cannot be addressed with emergency colostomy surgery alone;
• Previous systemic anti-cancer treatment for colorectal cancer;
• Coexistence of other non-colorectal cancer malignancies;
• Patients with any active autoimmune diseases, or a history of needing steroids or immunosuppressive drugs;
• Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);
• Previous treatment-induced any grade 2 or above toxicity reaction (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 classification) that has not subsided (excluding anemia, hair loss, and skin pigmentation);
• Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;
• Pregnant or breastfeeding women;
• Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
• Known or suspected allergy history to any drugs used in the trial.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

sintilimab

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

Central Study Contacts

Yueming Sun

CONTACT

025-68306026; jssym@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: October 5, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)