Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Compound Shuangdi Granule 1 sachet oral taken, twice a day for 4 weeks
Control group:Placebo 1 sachet oral taken, twice a day for 4 weeks
Sponsors
Fudan Universtiy Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. ICC patients who meet the criteria for diagnosis and treatment of primary liver cancer (2017 edition) issued by the National Health and Family Planning Commission, clinical diagnostic criteria and/or pathological tissue/cytological examinations diagnosed advanced or metastatic ICC patients, are not eligible for surgery, or recurrence and progression after surgery and/or other local treatments; 3. Have not previously received first-line systemic treatments (systemic chemotherapy, molecular targeting, immunotherapy, and research treatment drugs, etc.) for advanced or metastatic ICC, including but not limited to cisplatin, gemcitabine, etc.; 4. The time from the end of liver ablation or hepatic artery interventional therapy is more than 4 weeks, and the related adverse reactions return to normal; if after surgery or other local treatments, patients who have exceeded the norm and received systemic adjuvant chemotherapy, need to complete chemotherapy for more than 6 months, and disease progression and/or metastasis has occurred; 5. Within 2 weeks before the first medication, no modern Chinese Medicine preparations with liver cancer indications were used, including: Delisheng injection, Kanglaite injection or soft capsule, Aidi or Kangsaidi injection, elemene injection/oral Liquid, Huaier granules and Ganfule capsules/tablets, etc.; 6. No blood transfusion or blood products, no use of hematopoietic stimulating factors, no transfusion of albumin or blood products within 14 days before screening; 7. According to the solid tumor response assessment criteria (RECIST 1.1), at least one measurable target lesion is defined as: non-lymph node lesions with the longest single diameter >= 10 mm, or lymph node lesions with the short diameter >= 15 mm; for previous ablation or liver, the lesions after arterial interventional therapy and other local treatments must be examined by CT/MRI, and the disease progression must be determined according to the RECIST 1.1 standard, and the longest diameter >= 1.0 cm, before they can be used as measurable target lesions; 8. Child-Pugh liver function score = 12 weeks; 11. The main organ functions are basically normal and meet the following requirements: platelets >= 60 x 10^9/L, hemoglobin >= 85 g/L, white blood cells >= 3.0 x 10^9/L; total bilirubin = 28 g/L; serum creatinine = 50 ml/min; 12. If HBV-DNA >= 104 copies/ml (2000 IU/ml), antiviral liver protection treatment must be performed first, and only when HBV-DNA < 104 copies/ml (2000 IU/ml) can be included in the group; and continue to take antiviral drugs, monitor liver function and hepatitis B virus load; 13. Women of childbearing age must take a pregnancy test within 7 days before the start of treatment and the result is negative; for men of childbearing age: take effective contraceptive measures during the treatment and within 3 months after the end of the treatment; 14. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up; 15. Those who have not participated in other clinical trials within 4 weeks before screening; if other trials have failed to screen but meet the requirements of this trial, they can be included in the group.
Exclusion criteria
Exclusion criteria: 1. Imaging examination of HCC liver tumor is huge (>= 60% liver volume), or main portal vein tumor thrombus (occupying vascular diameter >= 50%), or tumor thrombus invades mesenteric vein or inferior vena cava; 2. Ascites of moderate or above clinical significance, which requires therapeutic abdominal puncture/drainage, or Child-Pugh score of this index > 2; 3. Received local anti-cancer treatment (including surgery, ablation, liver arterial chemotherapy/embolization or radiotherapy) or major surgery within 28 days before randomization; 4. Hepatocellular carcinoma and fibrolamellar cell carcinoma; 5. In the past 5 years or at the same time, there are other malignant tumors, except for cervical cancer in situ, basal cell carcinoma that has been treated, and superficial bladder tumors (Ta, Tis, T1); 6. Pregnant or lactating women; 7. Suffer from myocardial ischemia or myocardial infarction above CTCAE grade II, poorly controlled arrhythmia, and/or NYHA standard III-IV cardiac insufficiency; 8. Have previously received allogeneic organ transplantation, including liver transplantation, or plan to receive liver transplantation during the trial period; 9. Hepatic encephalopathy and/or hepatic nephropathy occurred within 6 months; 10. Active hepatitis C, that is, those who are anti-HCV positive or HCV-RNA positive and have abnormal liver function; 11. Human immunodeficiency virus (HIV) test results are positive, or serious infections that require systemic treatment with antibiotics; 12. Inability to swallow, chronic diarrhea or intestinal obstruction, which obviously affects the administration and absorption of the drug; 13. A history of gastrointestinal bleeding within 6 months, or a clear gastrointestinal bleeding tendency, including local active ulcer lesions, and positive stool occult blood; 14. The patient has a known active or suspected autoimmune disease; 15. Central nervous system metastasis is known to occur, and those suspected of central nervous system metastasis should be excluded by head MRI examination; 16. Obviously abnormal blood coagulation function: International Normalized Ratio (INR)> 1.5 or Prothrombin Time (PT)> 16 s; 17. Have schizophrenia, or a history of psychotropic drug abuse; 18. Known to be allergic or intolerant to the ingredients of Compound Shuangdi Granules; 19. The investigator considers other conditions that prevent the patient from participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Objective Response Rate;Disease Control Rate;Quality of Life;Traditional Chinese Medicine Scale for Intrahepatic Cholangiocarcinoma; | — |
Countries
China
Contacts
Public ContactChen Zhen
Fudan Unversity Shanghai Cancer Center
Outcome results
None listed