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Study on intestinal flora, metabonomics and microorganisms before and after hepatic artery infusion chemotherapy combined with lenvatinib and immunity in the treatment of middle and advanced unresectable hepatocellular carcinoma

Study on intestinal flora, metabonomics and microorganisms before and after hepatic artery infusion chemotherapy combined with lenvatinib and immunity in the treatment of middle and advanced unresectable hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087954
Enrollment
Unknown
Registered
2024-08-07
Start date
2023-11-07
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Hepatocellular carcinoma

Interventions

experimental group:Hepatic artery perfusion chemotherapy + lenvatinib + immune combination therapy

Sponsors

Zhongshan Hospital Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than 18 years old, gender is not limited; ECOGPS score: 0~2; 2. Clinical diagnosis of hepatocellular carcinoma (based on the Chinese primary liver cancer diagnosis and treatment standard 2022 edition); 3. Liver function grade is Child-Pugh class A or B; 4. Patients with ChinaCiverCancerStaging (CNLC) stage IIb, IIIa and IIIb. 5. Have not received other anti-tumor therapy in the past. 6. No contraindications to HAIC or target-free therapy; 7. Sign the informed consent and be able to comply with the requirements of the program; if the patient is unable to sign the informed consent, his/her legal guardian or agent should sign it.

Exclusion criteria

Exclusion criteria: 1. taking antibiotics, probiotics or microbial agents 1 month before and during the treatment; 2. have undergone surgical procedures related to gastrointestinal tract, liver, gallbladder, etc. in the last 1 month; 3. previous or concomitant other malignant tumors; 4. patients with combined serious diseases of heart, lung, kidney, brain, blood and other important organs; 5. patients with combined serious neurological and psychiatric diseases (e.g. epilepsy, depression, mania, seizures, schizophrenia, etc.); 6. patients with unstably controlled diabetes mellitus, hypertension, thyroid disease, etc.; patients with a history of severe retinopathy or indicated by other evidence of retinopathy; 7. Pregnant or breastfeeding women or patients who plan to become pregnant during the study period and are unwilling to use contraception; 8. Subjects whose current condition, in the opinion of the investigator, makes them unsuitable for participation in this study; 9. patients who are concurrently enrolled in other clinical research trials.

Design outcomes

Primary

MeasureTime frame
Intestinal flora;

Secondary

MeasureTime frame
Tissue metabolism;Intratumoral microorganisms;

Countries

China

Contacts

Public ContactYongjie Su

Zhongshan Hospital Xiamen University

syj_xm@163.com+86 136 1605 0526

Outcome results

None listed

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