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Trial Title:
Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation
NCT ID:
NCT06248554
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Immune Checkpoint Inhibitors
Conditions: Keywords:
Hepatocellular carcinoma
Adjuvant therapy
Microwave ablation
PD-1 inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 Inhibitors
Description:
Patients in the intervention group received post-operative adjuvant PD-1 inhibitor
therapy, 240 mg intravenously every three weeks for nine cycles
Arm group label:
PD-1 inhibitor adjuvant therapy group
Summary:
For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0,
ablation is the standard treatment with a comparable prognosis and less risk of ablation
compared with liver resection. However, ablation is demanding on the surgeon and patients
often face early recurrence if ablation is not complete. Therefore, it is necessary to
find reasonable adjuvant treatment to consolidate the effect of microwave therapy.
Detailed description:
For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0,
ablation is the standard treatment with a comparable prognosis and less risk of ablation
compared with liver resection. However, ablation is demanding on the surgeon and patients
often face early recurrence if ablation is not complete. Therefore, it is necessary to
find reasonable adjuvant treatment to consolidate the effect of microwave therapy. There
is no consensus on postoperative adjuvant therapy, especially for the management of
early-stage HCC. Most scholars believe that HCC in this period does not have high-risk
factors for tumor recurrence, thus neglecting the role of adjuvant therapy. Early studies
have found that microwave ablation can alter the tumor microenvironment, which is
conducive to the action of immune checkpoint inhibitors such as PD-1 inhibitors and even
has a synergistic anti-tumor effect. We therefore designed this prospective cohort study
to explore the efficacy and safety of adjuvant PD-1 inhibitors after microwave surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged 18-75 years
- Pathological type is HCC, BCLC stage 0-A
- No extrahepatic HCC
- No radiographic recurrence at 2-4 weeks after ablation
- Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
- Child-Pugh grade A or B and adequate hematologic and organ function
Exclusion Criteria:
- Any history of other malignant tumors or recurrent HCC
- Any preoperative treatment for HCC including local and systemic therapy
- Any acute active infectious diseases, active or history of autoimmune disease, or
immune deficiency
- Any persistent serious ablation-related complications
- Esophageal and/or gastric variceal bleeding within 6 months
- Inability or refusal to comply with the treatment and monitoring
- Participation in other clinical trials
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Address:
City:
WuHan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
WanGuang D Zhang
Phone:
+8613886195965
Email:
wgzhang@tjh.tjmu.edu.cn
Start date:
December 1, 2019
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Chen Xiaoping
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248554
