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Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer(Neo-Color)

StatusRecruiting
PhasePhase 2
Started2025-05-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 15 months later Feb 2027 → May 30, 2028
See other at-risk trials from Hebei Medical University Fourth Hospital

Amendment history

2026-07-30
critical
Study Status v4
Primary completion pushed: 2027-02 → 2028-05-30
Completion pushed: 2029-03 → 2030-03
2025-06-29
minor
Study Status, Eligibility v3
Eligibility criteria-14 characters
Inclusion Criteria: Age between ≥18 and 75 years, no restriction on gender. ECOG performance status of [...]
2025-06-17
minor
Study Identification, Study Status v2
Study title+11 characters
Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer(Neo-Color)
2025-06-04
minor
Study Status, Arms and Interventions v1
Start dateestimated 2025-05→confirmed 2025-05-15
2025-04-22
minor
Original filing
The goal of this clinical trial is to evaluate the efficacy and safety of conversion therapy using radiotherapy combined with systemic treatment (chemotherapy + immune checkpoint inhibitors) for patients with pMMR/MSS T4M0 stage colon cancer. The main questions it aims to answer are: 1. Can the combination of radiotherapy and systemic treatment improve the R0 resection rate and complete response (CR) rate compared to chemotherapy alone? 2. Does this combination therapy enhance the tumor immune microenvironment, leading to better long-term outcomes? Researchers will compare the experimental group receiving concurrent chemoradiotherapy (CCRT) followed by 4 cycles of CAPOX + Iparomlimab and Tuvonralimab Injection with the control group receiving 4 cycles of CAPOX alone to see if the combination therapy offers superior efficacy. Participants will: 1. Undergo preoperative CCRT combined with one cycle of Iparomlimab and Tuvonralimab Injection, followed by 4 cycles of CAPOX + Iparomlimab and Tuvonralimab Injection in the experimental group. 2. Receive 4 cycles of CAPOX in the control group. 3. After the initial treatment regimen, surgical candidates will undergo surgery followed by an additional 4 cycles of CAPOX. Non-surgical candidates will continue with 4 more cycles of CAPOX, completing a total of 8 cycles. Efficacy will be re-evaluated after the completion of 8 cycles.
Trial Details
NCT Number NCT06949111
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Colon Cancer
Enrollment 128 participants
Start Date 2025-05-15
Primary Completion 2028-05-30 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-03