OncoMatch/Clinical Trials/NCT03985891
The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer
Is NCT03985891 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Anti-PD-1 Monoclonal Antibody JS001 and Chemotherapy for colonic neoplasms.
Treatment: Anti-PD-1 Monoclonal Antibody JS001 · Chemotherapy — Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/neoadjuvant treatment for patients with locally advanced colon cancer.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor treatment
Pevious treatment with any anti-tumor treatment, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibodies or any other antibodies that target the T cell co-regulatory pathway), etc
Lab requirements
Blood counts
White blood cell count (WBC)≥2000/mm^3; Absolute neutrophil count (ANC)≥1000/mm^3; Blood platelet count ≥100000/mm^3; Hemoglobin ≥9g/d
Kidney function
Serum creatine ≤ 2.0mg/dL
Liver function
Serum total bilirubin (TBIL) is within the normal range (normal range specified by the institution; Total bilirubin of Gilbert syndrome <3.0mg/dL); Serum Aspartate Transaminase (AST), serum Alanine Aminotransferase Transaminase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 * upper limit of normal (ULN); International normalized ratio (INR) ≤1.5(or the patient is taking Warfarin for a long time, INR=2-3), and prothrombin time (PTT) ≤ULN
Cardiac function
Baseline ECG showes no PR interval prolongation or atrioventricular block
The main organs and bone marrow function are basically normal: (1) Blood test White blood cell count (WBC)≥2000/mm^ 3; Absolute neutrophil count (ANC)≥1000/mm^ 3; Blood platelet count ≥100000/mm^ 3; Hemoglobin ≥9g/d; Serum creatine ≤ 2.0mg/dL; (2) Liver function Serum total bilirubin (TBIL) is within the normal range (normal range specified by the institution; Total bilirubin of Gilbert syndrome <3.0mg/dL); Serum Aspartate Transaminase (AST), serum Alanine Aminotransferase Transaminase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 * upper limit of normal (ULN); International normalized ratio (INR) ≤1.5(or the patient is taking Warfarin for a long time, INR=2-3), and prothrombin time (PTT) ≤ULN (3) Pulmonary function Carbon Monoxide Diffusing Capacity (DLCO) ≥70% predictive OR; DLCO<70% and ≥55% , and the maximal oxygen consumption VO2 max ≥10L/min/Kg (cardiopulmonary assessment) or 6 minute walk experiment ≥500 meters; Patients with DLCO <55% are not included in this study; Pulse oximetry at rest or walking ≥92% (4) Cardiac function Baseline ECG showes no PR interval prolongation or atrioventricular block
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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