RecruitingPhase IIEN originalColorectal cancerEarly / localized

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18 lat lub więcej
  • Potwierdzona histopatologicznie diagnoza raka jelita grubego typu pMMR/MSS
  • Zaawansowana choroba (stadium T4, bez przerzutów)
  • Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-1)
  • Prawidłowe wyniki badań krwi i funkcji narządów
  • Gotowość do uczestnictwa w badaniu i podpisania zgody

✗ Disqualifies

  • Inne typy histologiczne raka (nie gruczolakorak)
  • Przerzuty do odległych narządów lub tkanek
  • Wcześniejsze leczenie radioterapią, chemioterapią lub immunoterapią
  • Aktywne choroby autoimmunologiczne wymagające długotrwałego leczenia immunosupresyjnego
  • Aktywne infekcje, w tym HIV lub zakaźne zapalenie wątroby
  • Ciężkie choroby sercowo-naczyniowe (zawał w ostatnich 6 miesiącach)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 3, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.

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