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A real-world study of camrelizumab combined with apatinib mesylate in unresectable hepatocellular carcinoma

A real-world study of camrelizumab combined with apatinib mesylate in unresectable hepatocellular carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061972
Enrollment
Unknown
Registered
2022-07-14
Start date
2022-08-20
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Hepatocellular carcinoma

Interventions

Group 1 :

Sponsors

Mengchao Hepatobiliary Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 years old = 10 mm or malignant lymph node short diameter >= 15 mm, see Annex 5/6 for mRECIST version 1.1); 3. Patients with unresectable hepatocellular carcinoma who have not received systemic therapy before or have progressed/intolerable after first-line systemic therapy; 4. CNLC stage is IIb-IIIb; 5. The Child-Pugh classification of liver function is grade A or grade B (5-7 points); 6. ECOGPS score 0-1 points; 7. Expected survival period >= 12 weeks; 8. If the patient suffers from active hepatitis B virus (HBV) infection: if HBV-DNA 2000, antiviral treatment should be given for one week before starting treatment; 9. Subjects voluntarily join this study, have good compliance, and cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with contraindications to immunotherapy, including but not limited to the following: patients after transplantation, patients with severe autoimmune diseases, patients with organ failure, patients with adverse reactions of grade 4 or above in the past using immunotherapy, and patients with uncontrollable infectious diseases patients, etc.; 3. Immunosuppressants or systemic hormone therapy were used within 14 days before enrollment to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other equivalent curative hormones); 4. Patients who have been confirmed to be allergic to camrelizumab injection, apatinib mesylate tablets and their excipients or to other monoclonal antibodies; 5. Patients with impaired consciousness or unable to cooperate with treatment, combined with patients with mental illness; 6. Patients who have participated in other clinical trials in the past three months; 7. Severe liver, kidney, heart, lung, brain and other major organ failure; 8. According to the investigator's judgment, patients with other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective Response Rate;Disease control rate;overall survival;Safety;

Countries

China

Contacts

Public ContactYongyi Zeng

Mengchao Hepatobiliary Hospital of Fujian Medical University

lamp197311@126.com+86 13805083802

Outcome results

None listed

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