OncoMatch/Clinical Trials/NCT04960072
A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital)
Is NCT04960072 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Tumor Infiltrating Lymphocytes (TIL) for gastrointestinal tumor.
Treatment: Tumor Infiltrating Lymphocytes (TIL) — This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gastrointestinal tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Performance status
KARNOFSKY/ECOG 0–2
Karnofsky≥60% or ECOG score 0-2
Prior therapy
Must have received: standard treatment regimens
Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
Cannot have received: malignant tumor-targeting therapies (including radiotherapy, chemotherapy and biologics)
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs
Cannot have received: other medicines, or other biologic therapy, chemo-or radiotherapy
Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy
Cannot have received: immunotherapy with irAE level greater than Level 3
Having received immunotherapy and developed irAE level greater than Level 3
Lab requirements
Blood counts
Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count≥100×10^9; hemoglobin≥90 g/L; Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)
Kidney function
Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min
Liver function
Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN
Hematology and Chemistry（within 7 days prior to enrollment）: * Absolute count of white blood cells≥2.5×10^9/L; * Absolute count of neutropils≥1.5×10^9/L; * Absolute count of lymphocytes ≥0.7×10^9/L； * Platelet count≥100×10^9； * hemoglobin≥90 g/L; * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); * Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; * Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); * Totol bilirubin≤1.5×ULN;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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