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Effects of high exposure to traditional Chinese medicine on the efficacy and safety of PD-1 in the treatment of hepatocellular carcinoma: Prospective, observational, one-arm study

Effects of high exposure to traditional Chinese medicine on the efficacy and safety of PD-1 in the treatment of hepatocellular carcinoma: Prospective, observational, one-arm study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049159
Enrollment
Unknown
Registered
2021-07-24
Start date
2021-07-26
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

HCC

Interventions

Experimental group:Carrelizumab + traditional Chinese medicine exposure

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, gender unlimited; 2. HCC confirmed by histology/cytology or imaging meets the clinical diagnostic criteria of the 2019 edition of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer; 3. No systemic antitumor therapy was received within the first six months of enrollment; 4. At least one measurable lesion (MRECIST); 5.BCLC staging: A-B; 6.Child-Pugh score <=9 points; 7.ECOG physical status score 0~2 points; 8. For women of childbearing age or male patients whose sexual partners are women of childbearing age, effective contraceptive measures should be taken throughout the treatment period and within 6 months after the last medication; 9. Sign the written informed consent, and can comply with the protocol and family consent to participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. A history of other tumors within 1.5 years; 2. Previous histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.; 3. Patients with a large number of cancerous ascites and brain metastases; 4. Main portal vein tumor thrombus also involved contralateral portal vein branch; 5. Local treatment, including hyperthermia, TACE and radiotherapy, was given within two months before enrollment; 6. Patients with liver cancer who plan to undergo liver transplantation or surgical resection; 7. Severe infections in active stage or poorly controlled clinically; 8. Grade II heart failure, centrifuge ischemia and uncontrollable arrhythmia; 9. Any hemorrhage event of esophageal or fundus varices caused by portal hypertension in the past 6 months or any life-threatening bleeding event in the past 3 months; 10. Diseases that affect the efficacy of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.; 11. Have contraindications to microwave hyperthermia; Have a history of PD-1 antibody allergy; 12. Pregnant and lactating women; 13. Subjects the investigator deems unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
objective response rate;disease control rate;overall survival;adverse event rate;Probability of serious adverse events;

Countries

China

Contacts

Public ContactLi Ping

The First Affiliated Hospital of Anhui Medical University

aydliping@163.com+86 13965112719

Outcome results

None listed

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