A Study of TIL in Advanced Solid Tumors (DFGD)

• GC203 TIL(gene-edited TIL) or autologous TILs (Biological): the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample

Primary outcomes

• Adverse Events [6 months]: To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.

Secondary outcomes

• Objective Response Rate (ORR) [Up to 36 months]: Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Disease Control Rate (DCR） [Up to 36 months]: Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1
• Duration of Response (DOR) [Up to 36 months]: The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
• Progression-Free Survival (PFS) [Up to 36 months]: The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* have one the tumor resection for TILs production and successfully produced；
* Age: 18 years to 75years;
* Histologically diagnosed as solid tumors;
* Expected life-span more than 3 months;
* ECOG score 0-1;
* Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;
* At least 1 evaluable tumor lesion;

Exclusion Criteria:

* with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is < 95%;
* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
* Significant cardiovascular anomalies

• Qian Zhang, Principal investigator, Eastern Hepatobiliary Surgery Hospital
• Wenlong Yu, Principal investigator, Eastern Hepatobiliary Surgery Hospital