NCT07140679

Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the efficacy of adjuvant toripalimab in patients with resected stage IIB, IIC, and III mismatch repair deficient (dMMR) colon cancer by measuring 3-year disease-free survival. SECONDARY OBJECTIVES: I. Define the immune related toxicity profile of toripalimab in the adjuvant setting. II. Further evaluate the efficacy of adjuvant toripalimab specifically by measuring 3-year relapse free survival (RFS), 5-year disease free survival (DFS), and 5-year overall survival. TERTIARY/EXPLORATORY OBJECTIVES: I. To explore immune, ctDNA, and omic markers associated with clinical efficacy (DFS). II. To assess patient reported outcomes (PRO) and health related quality of life (QoL). OUTLINE: Eligible consenting participants will receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months until 5 years post-resection. After completion of study medication, participants undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. Patient reported outcomes and quality of life will also be assessed with questionnaires.

Conditions

• Localized Colon Carcinoma
• Stage IIB Colon Cancer AJCC v8
• Stage IIC Colon Cancer AJCC v8
• Stage III Colon Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Colonoscopy	Undergo colonoscopy
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Toripalimab	Given IV

Timeline

• Start date: 2025-09-19
• Primary completion: 2029-09-30
• Completion: 2029-12-31
• First posted: 2025-08-25
• Last updated: 2025-09-25

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study