💬In plain words
What the trial is, and whether it could suit you
A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
To be included in the trial, participants must meet all of the following criteria:
1. Volunteer to participate in the clinical trial; fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
2. Age 18-75 years, inclusive, male or female;
3. Initially diagnosed with CNLC stage IIIa HCC with any of the following vascular tumor thrombi and absence of atrial tumor thrombi on preoperative imaging:
* Portal vein tumor thrombus (PVTT);
* Hepatic vein tumor thrombus (HVTT);
* Inferior vena cava tumor thrombus (IVCTT);
4. Has undergone surgical resection:
* Pathological evaluation of surgical resection specimen with negative margins;
* Preoperative conversion/neoadjuvant therapy and/or postoperative therapy are allowed;
5. The participant has recovered from liver resection and postoperative progressive increase in AFP level(including: a. AFP increase of at least 20% in any 3 months after surgery; or b. AFP increase of ≥ 10% in any 2 consecutive tests after surgery) with a potential tendency to recurrence as assessed by the investigator.
6. Tumor tissue samples positive for GPC3 by immunohistochemistry (IHC) (staining intensity ≥ 1 +, percentage of stained tumor cells ≥ 10%);
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days prior to apheresis);
8. Child-Pugh score ≤ 7 points (within 7 days prior to apheresis);
9. Estimated survival \> 12 weeks;
10. Adequate venous access for apheresis;
11. Laboratory test results within 7 days prior to apheresis should meet the following criteria (if the laboratory test results do not meet the following criteria, a repeat test within 1 week is allowed; if the laboratory test results still do not meet the criteria, it will be considered a screening failure):
* Hematology (without transfusion, platelet transfusion, colony-stimulating factor and other supportive treatment within 7 days before detection, except recombinant human erythropoietin): neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count (LY) ≥ 0.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L, hemoglobin (Hb) ≥ 9.0 g/dL; The results of hematology within 24 hours before apheresis shall also meet this standard;
* Blood chemistry: serum creatinine ≤ 1. 5 × upper limit of normal (ULN), endogenous creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 5×ULN, aspartate aminotransferase (AST) ≤ 5 × ULN, alkaline phosphatase (ALP) ≤ 5 × ULN, total bilirubin (TBil) ≤ 3 × ULN, serum albumin (ALB) ≥ 28 g/L, and serum lipase and amylase ≤ 2 × ULN;
* Prothrombin time (PT) prolongation ≤ 4 s;
12. Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to remain abstinent or use highly effective and reliable contraception (\< 1% failure rate per year) during the treatment period and for at least 1 year after the last dose of trial treatment, during which time they must not donate eggs:
* Women of childbearing potential are defined as women who have not reached post-menarche but have not reached a post-menopausal state (no menses for ≥ 12 consecutive months, with no cause other than menopause) and who have not been permanently infertile due to surgery (removal of ovaries, fallopian tubes, and/or uterus) or other reasons (e.g. M ü llerian agenesis, etc.) as determined by the investigator;
* Contraceptive methods with an annual failure rate of \< 1% include: bilateral tubal ligation, male sterilization, approved hormonal contraceptives, hormone-releasing intrauterine devices, copper-containing intrauterine devices; Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation rhythm methods) and withdrawal are not adequate methods of contraception.
13. Male participants who are sexually active with a female of childbearing potential, who have not had a vasectomy, must agree to remain abstinent or to use contraception (e.g., condoms in combination with other contraceptive measures to achieve an annual failure rate of \< 1%, see inclusion criterion # 12) during the treatment period and for 1 year after the last dose of study treatment and refrain from donating sperm during this period.
Exclusion Criteria:
Participants were not included in the trial if they met any of the following criteria:
1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma;
2. Intrahepatic recurrence or extrahepatic metastasis, or residual hepatocellular carcinoma detected before apheresis (imaging evidence according to RECIST v1.1);
3. More than 2 years since surgical resection;
4. Pregnant or lactating females;
5. Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis C virus (HCV) ribonucleic acid (RNA), hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] ≥ 1000 IU/mL (HBsAg-positive or HBcAb-positive participants must receive antiviral therapy), cytomegalovirus (CMV) DNA, Epstein-Barr virus (EBV) DNA;
6. Any uncontrolled active infection, including but not limited to active tuberculosis, infectious diseases requiring systemic treatment, etc.; Patients who use drugs to prevent infection can be enrolled at the discretion of the investigator;
7. Subjects with clinically significant abnormal thyroid function (free triiodothyronine \[FT3\], free thyroxine \[FT4\] and serum thyroid stimulating hormone \[TSH\] for serum thyroid hormones, and total thyroxine \[TT4\] and total triiodothyronine \[TT3\] for serum thyroid hormones if necessary) judged by the investigator and not suitable for entry into the trial after assessment; Patients with stable thyroid function after treatment can be considered for inclusion;
8. Previous or current hepatic encephalopathy;
9.