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Conversion of initially unresectable hepatocellular carcinoma associated using tyrosine kinase inhibitor and anti-PD-1 antibody who then adopt surgical resection versus continued targeted immunotherapy:a multicenter, prospective cohort study.

Conversion of initially unresectable hepatocellular carcinoma associated using tyrosine kinase inhibitor and anti-PD-1 antibody who then adopt surgical resection versus continued targeted immunotherapy:a multicenter, prospective cohort study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069511
Enrollment
Unknown
Registered
2023-03-20
Start date
2023-03-20
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Hepatocellular carcinoma

Interventions

Operation group:Surgical removal of tumor
Non-operative group:Continue targeted immunotherapy

Sponsors

Eastern Hepatobiliary Surgery Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable hepatocellular carcinoma before treatment are generally in good condition with an estimated overall survival time of more than 6 months. 2. All patients were successfully transformed by targeted therapy combined with immunotherapy. 3. All patients had primary liver cancer confirmed by MRI or CT, and the imaging data were complete, which could determine the remission time. 4. Preoperative liver function assessment Child-Pugh grade was A or B, and prothrombin time (PT) was less than 4 seconds of normal control. Gastroscopy esophageal vein without severe varicosity, no active digestive tract ulcer. No hepatic encephalopathy or/and moderate or above ascites. Renal function and cardiopulmonary function are basically normal. Hemoglobin =90g/L, white blood cell count =3.0×109/L, neutrophil count =1.5×109/L, platelet count =60×109/L, no definite cachexia; 5. No pregnancy, HIV or syphilis infection, understanding of the study and signed an informed consent.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis of tumor has occurred, such as metastasis of lung, brain, bone, etc 2. Patients who did not meet the requirement of surgical resection after conversion therapy 3. Patients with severe varicose esophagus and gastric fundus veins, tendency of gastrointestinal bleeding, or history of massive gastrointestinal bleeding; 4. Patients with heart, lung and renal insufficiency. Oral administration of warfarin and other anticoagulant drugs within 2 weeks. 5. Researchers believe that participants should not participate in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
Survival time;

Secondary

MeasureTime frame
Duration of remission;

Countries

China

Contacts

Public Contactshuqun Cheng

Eastern Hepatobiliary Surgery Hospital

chengshuqun@aliyun.com13901746139

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026