One-arm, open clinical study on the efficacy and safety of Jianpi Xiaoji Recipe in the treatment of advanced primary liver cancer

Phase 1

Conditions: iver cancer

Registration Number: ITMCTR1900002751

Lead Sponsor: Guangxi Medical University Affiliated Tumor Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) The age is 18 to 75 years old; the ECOG system status (PS) is 0 to 2 points; the expected survival period is not less than 12 weeks;
(2) Pathologically confirmed or clinically diagnosed advanced primary liver cancer (HCC), Barcelona primary liver cancer clinical stage (BCLC) C, and not suitable for surgery or local treatment, or after surgery and / or local treatment;
(3) Child-Pugh liver function rating: grade A and better grade B (<= 7 points and hepatic encephalopathy score of 1);
(4) Previous treatment with molecular targeted therapy (sorafenib and its analogs, etc.) or/and systemic chemotherapy (single or combined) failed (disease progression or toxicity intolerance); sorafenib-like drugs include: Vatinib, sorafenib, surrogate;
(5) The main organs function normally, that is, they meet the following criteria:
1) Blood routine examination standards must meet:
a) ANC >= 1.5 x 10^9 / L;
b) Hb >= 90g/L;
c) PLT >= 90 x 10^9 / L;
(No blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors).
2) Biochemical examinations must meet the following criteria:
a) TBIL<3 x ULN;
b) ALT and AST < 5 x ULN;
c) BUN and Cr <= 1 x ULN or endogenous creatinine clearance >= 5Oml / min (Cockcroft-Gault formula);
(6) Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days prior to enrollment and the results were negative, and were willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent must be given to the appropriate method of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug;
(7) Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.

Exclusion Criteria

(1) Known as hepatobiliary cell carcinoma or mixed cell carcinoma or fibrostratic cell carcinoma; currently or previously suffering from other malignant tumors (except for well-treated skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ), radically Except for treatment and evidence of no recurrence of metastasis within the last 5 years;
(2) Symptomatic central nervous system or pia mater metastasis (patients with brain metastasis who have completed treatment and stable symptoms 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography. Bleeding symptoms);
(3) Toxic effects of grade 1 or higher (CTCAE 5.0 grade) are still attributable to any previous treatment toxicity (except for any level of hair loss);
(4) Patients with a history of previous liver transplantation or who are ready for liver transplantation;
(5) Major surgery or severe traumatic injury, fracture or ulcer in the first 4 weeks of enrollment;
(6) Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
(7) Serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and need for symptomatic treatment;
Note: Asymptomatic serous effusion can be enrolled, symptomatic serous effusion after active symptomatic treatment (can not use anticancer drugs for the treatment of serosal effusion), the researchers judged suitable for enrollment Patient, allowed to join;
(8) Active infections require anti-microbial treatment (eg antibiotics, antiviral drugs, and chronic hepatitis B anti-hepatitis B treatments);
(9) A person with a history of psychotropic substance abuse who is unable to quit or has a mental disorder;
(10) Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment;
(11) Previous or concurrently with other unhealed malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer;
(12) Pregnant or lactating women: those who have fertility are unwilling or unable to take effective contraceptive measures;
(13) The investigator judges other conditions that may affect clinical research, data and sample collection, and research findings.