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A prospective, small sample, exploratory study of TACE combined with anlotinib in the treatment of primary hepatocellular carcinoma with lung metastasis

A prospective, small sample, exploratory study of TACE combined with anlotinib in the treatment of primary hepatocellular carcinoma with lung metastasis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056221
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-03-03
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

advanced hepatocarcinoma

Interventions

Experimental group:TACE + anlotinib

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with hepatocellular carcinoma confirmed histologically or cytologically; Or meet the clinical diagnostic criteria for liver cancer; 2. Estimated survival >= 3 months; 3. Aged between 18 and 75; 4. Good general condition, ECOG general condition score 0-2; 5. The intrahepatic primary lesion is a massive or nodular type; 6. With pulmonary metastasis; 7. Liver function child A or B; BCLC stage C with pulmonary metastasis; 8. No previous history of radiotherapy, chemotherapy, or biotherapy; 9. No serious complications, such as renal insufficiency or cardiac insufficiency; No history of severe iodine allergy; 10. Patient informed consent, good compliance, can follow up.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis of the tumor other than pulmonary metastasis; 2. Biliary tract obstruction due to tumor invasion; 3. Patients with known or symptomatic BMS who have not been ruled out by further examination; 4. Diffuse tumor of the liver; 5. Tumor load >50%; 6. Portal body shunt or hepatic arteriovenous fistula is known; 7. Congestive heart Failure > New York Heart Association (NYHA) Grade 2; Uncontrolled high blood pressure; 8. History of human immunodeficiency virus (HIV) infection; 9. Renal failure or insufficiency requiring hemodialysis or peritoneal dialysis; 10. Any prior treatment of the target lesion; 11. Severe active clinical infection (grade > 2, NCI-CTCAE version 4.0), except HBV and HCV infection; 12. Upper gastrointestinal bleeding or definite tendency of gastrointestinal bleeding within 4 weeks before the start of the test; 13. Any contraindications of anlotinib or doxorubicin/pirubicin; 14. Subjects who are pregnant or breastfeeding; 15. Women of childbearing age must use contraception for themselves and their spouses; 16. Received other molecularly targeted drugs within 4 weeks prior to trial initiation; 17. Patients who had major surgery (e.g., intra-thoracic, intra-abdominal, or pelvic) or who have not recovered from the side effects of such surgery in the 4 weeks prior to trial initiation; 18. Combined with other malignant tumors (patients who have been cured 3 years ago can be included) 19. Prior systemic chemotherapy; 20. Patients who have previously received radical treatment (surgery, liver transplantation, ablation) must have a new target at the time of enrollment; 21. For patients who have previously received TACE and other local treatments, the original lesion cannot be used as the target lesion, and a new target lesion must be found at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
Time to progression;

Secondary

MeasureTime frame
Disease control rate;Overall survival time;Adverse reaction;

Countries

China

Contacts

Public ContactHongtao Hu

Henan Cancer Hospital

13592616373@163.com+86 13592616373

Outcome results

None listed

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