UnknownPhase 1

Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells

China20 participantsStarted 2019-07-23

Plain-language summary

To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients should sign informed consent form voluntarily and comply with the requirements of this study.
✓. Gender unlimited, age 18 to 70 years old.
✓. Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
✓. According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
✓. Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
✓. Expected survival ≥ 6 months.
✓. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study.

✕. Combine other viral liver diseases or other liver disease patients.
✕. Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
✕. Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
✕. Dysfunction of major organs; patient white blood cell count \<1.0×10e9/L, platelet count \<60×10e9/L, hemoglobin \<86g/L, prothrombin time (INR) \>2.3, or prolonged clotting time \>6 seconds, serum albumin \<28g/L, total bilirubin \>51mmol/L, ALT/AST \>5 times the upper limit of normal, creatinine \>1.5 times the upper limit of normal.
✕. Combined with other serious organic diseases, mental illnesses, including any uncontrolled clinically significant systemic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.
✕. Allergic constitution, history of allergies to blood products, known to be allergic to test substances.
✕. Immunosuppressive or systemic cytotoxic drugs may require within six months prior to screening or during treatment; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.; immunotherapy such as PD-1 and PD-L1 antibodies.
✕. Patients currently participating in other clinical trials who may violate this treatment plan and observations.

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Timeframe: 14 months

Overall survival (OS)

Timeframe: 14 months

NCT IDNCT04032392

SponsorBeijing 302 Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-30

Yuanyuan Li, Dr

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients should sign informed consent form voluntarily and comply with the requirements of this study.
✓. Gender unlimited, age 18 to 70 years old.
✓. Hepatocellular carcinoma histopathology proven by liver fresh biopsy.
✓. According to the 2018 edition of the EASL guidelines for primary liver cancer, patients were diagnosed with advanced HBV-related hepatocellular carcinoma (BCLC stage B and C) by pathology and imaging; all patients required antiviral therapy with nucleoside analogues; other treatments (e.g. interventional therapy) at least 2 weeks prior to γδT cell infusion; patients can take the first- or second-line targeted drugs recommended by the guidelines, such as lenvatinib or sorafenib.
✓. Liver function: Child-Pugh class A/B (5-9), Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
✓. Expected survival ≥ 6 months.
✓. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study.

✕. Combine other viral liver diseases or other liver disease patients.
✕. Acute infection, gastrointestinal bleeding, etc. occurred within 30 days before screening.
✕. Pregnant or lactating women; patients after organ transplantation; patients with severe autoimmune diseases; patients with uncontrolled infectious diseases.
✕. Dysfunction of major organs; patient white blood cell count \<1.0×10e9/L, platelet count \<60×10e9/L, hemoglobin \<86g/L, prothrombin time (INR) \>2.3, or prolonged clotting time \>6 seconds, serum albumin \<28g/L, total bilirubin \>51mmol/L, ALT/AST \>5 times the upper limit of normal, creatinine \>1.5 times the upper limit of normal.
✕. Combined with other serious organic diseases, mental illnesses, including any uncontrolled clinically significant systemic diseases such as urinary, circulatory, respiratory, neurological, psychiatric, digestive, endocrine and immune diseases.
✕. Allergic constitution, history of allergies to blood products, known to be allergic to test substances.
✕. Immunosuppressive or systemic cytotoxic drugs may require within six months prior to screening or during treatment; 6 months prior to screening accepted other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc.; immunotherapy such as PD-1 and PD-L1 antibodies.
✕. Patients currently participating in other clinical trials who may violate this treatment plan and observations.