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Treatment of Liver Cancer: A Multi-Center, Real-World Research

Treatment of Liver Cancer: A Multi-Center, Real-World Research

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051057
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-09-10
Completion date
Unknown
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cancer

Interventions

Experimental group:Different anti-tumor treatments

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, male or female; 2. Patients with hepatocellular carcinoma diagnosed by imaging or pathological examination; 3. Those who are inoperable for initial treatment, those who cannot be re-operated after recurrence, those who recur or remain after RFA/TACE treatment and cannot be re-operated; 4. Expected survival period >= 3 months; 5. Child-Pugh score: grade A or better grade B (= 29g/L; 6. ECOG score: 0-2 points; 7. There are measurable lesions that meet the mRECIST criteria; 8. Hematological examinations meet: HB >= 90g/L, ANC >= 1.5x10^9/L, PLT >= 75 x 10^9/L, WBC >= 3.0 x 10^9/L; 9. Patients with hepatitis B and C virus infection should have effective antiviral therapy, HBV DNA < 100IU/ml, HCV DNA <100IU/ml; 10. Agree to join the group, be willing to cooperate with clinical research, and sign the informed consent; 11. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

Exclusion criteria

Exclusion criteria: 1. History of esophagogastric varices bleeding, hepatic encephalopathy, massive ascites, and abdominal infection; 2. The tumor is close to the organs at risk such as the intestine, and it is difficult to tolerate radiotherapy; the residual liver volume is less than 700ml, and it is difficult to tolerate radiotherapy; 3. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation; 4. Prior use of immunosuppressive drugs within 14 days prior to use of immunotherapy, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day prednisolone or equivalent pharmacological doses of other corticosteroids); 5. Known severe allergic reactions to immune or targeted drugs; 6. Administer a live attenuated vaccine within 4 weeks before the first dose or during the study period; 7. The presence of peripheral neuropathy > grade 1; 8. Have any active autoimmune disease or a history of autoimmune disease; 9. Have ever been diagnosed with any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; 11. Hypertension, which cannot be well controlled by antihypertensive drug treatment (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 12. Abnormal coagulation function (APTT > 1.5xULN), with bleeding tendency or receiving thrombolytic therapy, anticoagulation therapy or antiplatelet therapy, etc.; 13. Known hereditary or acquired bleeding and thrombotic tendencies, such as: hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.; 14. Patients with obvious coughing up blood within 2 months before entering the study; 15. Patients at risk of gastrointestinal bleeding, including the following: (1) Active peptic ulcer lesions; (2) Those with a history of melena and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it is necessary to review the stool routine within 1 week, and for those who are still (+) or (+/-), gastroscope examination is required, if there are ulcers, bleeding disorders, and Those who are considered by the treating physician to have a potential bleeding risk; 16. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, that occurred within 6 months before entering the study. 17. Complicated infection requiring drug intervention within 4 weeks before the first dose (such as: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during screening/before the first dose; 18. Participated in any other drug clinical research within 4 weeks before the first administration; 19. Known history of psychotropic substance abuse or drug use; 20. There are other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator considers unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
progression-free survival;overall survival;

Countries

China

Contacts

Public ContactHan Yunwei

Affiliated Hospital of Southwest Medical University

572515617@qq.com+86 15883000220

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026