Phase
Condition
Colorectal Cancer
Colon Cancer
Treatment
Iparomlimab and Tuvonralimab Injection
CAPOX
Capecitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years, no restriction on gender.
ECOG performance status of 0-1.
Histopathologically confirmed diagnosis of colon adenocarcinoma (including mucinousadenocarcinoma), identified as pMMR/MSS type; the primary tumor site must bespecified (left colon defined as from the splenic flexure to the rectosigmoidjunction, right colon defined as from the cecum to the proximal splenic flexure).
Baseline imaging (enhanced CT/MRI) confirms clinical staging as cT4NanyM0 accordingto 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 ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN, creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula).
(3) Coagulation function: INR ≤ 1.5, APTT ≤ 1.5 × ULN (for those not on anticoagulation therapy).
6.Women of childbearing potential and men must agree to use effective contraception during the study and for 6 months after the last treatment.
7.Willingness to sign a written informed consent form and commit to completing the entire treatment and follow-up plan.
Exclusion
Exclusion Criteria:
Histological type of neuroendocrine carcinoma, squamous cell carcinoma, or othernon-adenocarcinoma components comprising more than 50%.
Presence of distant metastasis (including peritoneal metastasis, non-regional lymphnode metastasis, or organ metastasis).
Previous radiotherapy, chemotherapy, targeted therapy, or immunotherapy for coloncancer.
Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritisrequiring long-term immunosuppressive therapy).
Active infections (e.g., HIV, positive HBV/HCV viral load requiring antiviraltreatment 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, cervicalcarcinoma in situ, etc., with a disease-free period of ≥5 years).
Uncontrolled diabetes (HbA1c > 8%) or thyroid dysfunction (TSH outside the normalrange requiring medication).
Severe chronic bowel diseases (e.g., active Crohn's disease, ulcerative colitis).
History of radiation enteritis or extensive abdominal adhesions affectingradiotherapy target delineation.
Unrecovered bone marrow suppression (ANC < 1.5 × 10^9/L, PLT < 100 × 10^9/L, Hb < 90g/L).
Liver function with Child-Pugh score ≥ B or renal function with eGFR < 60mL/min/1.73 m².
Pregnant or breastfeeding women (blood/urine HCG test required during screening).
Cognitive impairment or history of psychiatric disorders affecting treatmentcompliance.
Concurrent participation in other interventional clinical trials.
Patients deemed unsuitable for participation by the investigator.
Study Design
Connect with a study center
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaActive - Recruiting
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