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New treatment option for Colon Cancer
Official title Radiotherapy + Systemic Therapy as Conversion Therapy for pMMR/MSS T4M0 Colon Cancer（Neo-Color）
ClinicalTrials.gov ID: NCT06949111
What this study is testing
What is CAPOX?
CAPOX is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for colon cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, no restriction on gender.
- ECOG performance status of 0-1.
- Histopathologically confirmed diagnosis of colon adenocarcinoma (including mucinous adenocarcinoma), identified as pMMR/MSS type; the primary tumor...
- Baseline imaging (enhanced CT/MRI) confirms clinical staging as cT4NanyM0 according to the AJCC 8th edition staging criteria.
- Laboratory criteria prior to enrollment must meet the following ranges: (1) Hematology: Absolute neutrophil count ≥ 1.5 × 10\^9/L, platelets ≥ 100 ×...
You likely can't join if
- Histological type of neuroendocrine carcinoma, squamous cell carcinoma, or other non-adenocarcinoma components comprising more than 50%.
- Presence of distant metastasis (including peritoneal metastasis, non-regional lymph node metastasis, or organ metastasis).
- Previous radiotherapy, chemotherapy, targeted therapy, or immunotherapy for colon cancer.
- Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy).
- Active infections (e.g., HIV, positive HBV/HCV viral load requiring antiviral treatment for stabilization).
- Severe cardiovascular diseases (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg).
See the full eligibility criteria
- Age ≥18 years, no restriction on gender.
- ECOG performance status of 0-1.
- Histopathologically confirmed diagnosis of colon adenocarcinoma (including mucinous adenocarcinoma), identified as pMMR/MSS type; the primary tumor site must be specified (left colon defined as from the splenic flexure...
- Baseline imaging (enhanced CT/MRI) confirms clinical staging as cT4NanyM0 according to the AJCC 8th edition staging criteria.
- Laboratory criteria prior to enrollment must meet the following ranges: (1) Hematology: Absolute neutrophil count ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L. (2) Liver and renal function: ALT/AST ≤...
- Histological type of neuroendocrine carcinoma, squamous cell carcinoma, or other non-adenocarcinoma components comprising more than 50%.
- Presence of distant metastasis (including peritoneal metastasis, non-regional lymph node metastasis, or organ metastasis).
- Previous radiotherapy, chemotherapy, targeted therapy, or immunotherapy for colon cancer.
- Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy).
- Active infections (e.g., HIV, positive HBV/HCV viral load requiring antiviral treatment for stabilization).
- Severe cardiovascular diseases (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg).
- History of other malignancies (except for cured non-melanoma skin cancer, cervical carcinoma in situ, etc., with a disease-free period of ≥5 years).
- Uncontrolled diabetes (HbA1c \> 8%) or thyroid dysfunction (TSH outside the normal range requiring medication).
- Severe chronic bowel diseases (e.g., active Crohn's disease, ulcerative colitis).
- History of radiation enteritis or extensive abdominal adhesions affecting radiotherapy target delineation.
- Unrecovered bone marrow suppression (ANC \< 1.5 × 10\^9/L, PLT \< 100 × 10\^9/L, Hb \< 90 g/L).
- Liver function with Child-Pugh score ≥ B or renal function with eGFR \< 60 mL/min/1.73 m².
- Pregnant or breastfeeding women (blood/urine HCG test required during screening).
- Cognitive impairment or history of psychiatric disorders affecting treatment compliance.
- Concurrent participation in other treatment clinical trials.
- Patients deemed unsuitable for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.