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TACE sequential MWA combined with carririzumab and apatinib in the treatment of hepatocellular carcinoma: a prospective, open, single-arm, single-center clinical study

TACE sequential MWA combined with carririzumab and apatinib in the treatment of hepatocellular carcinoma: a prospective, open, single-arm, single-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048076
Enrollment
Unknown
Registered
2021-06-30
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Hepatocellular carcinoma(HCC)

Interventions

Case series:Camrelizumab + apatinib+TACE sequential MWA

Sponsors

The First Affiliated Hospital of Bengbu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. HCC diagnosed by histology/cytology or clinically meets the clinical diagnostic criteria of the 2019 version of the diagnosis and treatment of primary liver cancer; 3. CNLC Ib-CNLC IIIb hepatocellular carcinoma patients who are not suitable for surgery; 4. Did not receive systemic anti-tumor therapy within half a year before enrollment; 5. There is at least one measurable lesion (mRECIST); 6. Child-Pugh score = 9 points; 7. ECOG physical status score 0-2 points; 8. The expected survival period is =12 weeks; 9. It has sufficient organ and bone marrow functions, and the laboratory examination values 7 days before entry meet the following requirements: 1) Blood routine: ANC>=1.5x10^9/L, PLT>=50x10^9/L, HGB>=9.0g/dL; 2) Liver function: TBIL<=2 ULN, ALT and AST<=5 ULN 10. Females of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures during the entire treatment period and within 6 months after the last medication; 11. Sign a written informed consent form, and can comply with the provisions of the plan and the family members agree to join the clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There is a history of other tumors within 5 years; 2. Previously diagnosed by histology/cytology with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 3. Patients with large amounts of cancerous ascites and brain metastases; 4. The main portal vein tumor thrombus involves the contralateral portal vein branch at the same time; 5. Local treatments including ablation, TACE, and radiotherapy were performed within two months before enrollment; 6. Liver cancer patients who plan to undergo liver transplantation or surgical resection; 7. Severe infections in active phase or poor clinical control; 8. There are grade II heart failure, myocardial ischemia and uncontrollable arrhythmia; 9. Esophageal or gastric varices bleeding caused by portal hypertension occurred within the past 6 months, or any life-threatening bleeding event occurred within 3 months; 10. Diseases that affect the efficacy of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.; 11. Subjects who have had serious adverse reactions to iodinated contrast media; 12. Pregnant and lactating women; 13. Subjects considered by the investigator to be unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
ProgressionFreeSurvival;

Secondary

MeasureTime frame
OverallSurvival;Objective response rate;Disease Control Rate;Drug safety;

Countries

China

Contacts

Public ContactYuan Mu

The First Affiliated Hospital of Bengbu Medical College

lczhc999@163.com+86 13855227341

Outcome results

None listed

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