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

NCT06108596 | Completed Phase 2 DMC

• 1 other identifier: PRSYM202310
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Rectal Adenocarcinoma

Keywords

Immunotherapy treatment; IL-2; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• pCR

  To evaluate whether neoadjuvant Sintilimab with Interleukin-2+CAPOX would significantly improve the pathological complete response (pCR) proportion in patients with locally advanced rectal cancer

  From the start of initial medication to the final determination via pathology results after surgical treatment, the assessment period will be up to a maximum of 6 months.

Secondary Outcomes (5)

• cCR

  From the start of initial medication to the end of six cycles of treatment, with final determination based on radiological examination, endoscopic examination results, and other assessments, the assessment period will be up to a maximum of 6 months.

• R0 resection rate R0 resection rate

  From the start of initial medication to the final determination via pathology results after surgical treatment, the assessment period will be up to a maximum of 6 months.

• Major pathological response (MPR)

  From the start of initial medication to the final determination via pathology results after surgical treatment, the assessment period will be up to a maximum of 6 months.

• Adverse Event

  From the start of initial medication to the end of six cycles of treatment, the assessment period will be up to 1 month after the last treatment.

• Complications within 30 days post-surgery

  within 30 days post-surgery

Study Arms (1)

Experimental group

EXPERIMENTAL

Sintilimab with Interleukin-2+CAPOX

Drug: Sintilimab with Interleukin-2+CAPOX

Interventions

Sintilimab with Interleukin-2+CAPOX DRUG

Sintilimab with Interleukin-2+CAPOX

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 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.

You may not qualify if:

• 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;
• 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);
• 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;
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210000, China

Location

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

Study Officials

• Yueming Sun

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

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: October 25, 2023
• First Posted: October 31, 2023
• Study Start: October 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)