OncoMatch/Clinical Trials/NCT04960072
A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital)
Is NCT04960072 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT04960072 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior malignant tumor-targeting therapies (including radiotherapy, chemotherapy and biologics), other medicines, or other biologic therapy, chemo-or radiotherapy, immunotherapy with irAE level greater than Level 3 disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages