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Chemotherapy With the Ralox Regimen Combined With Anlotinib and Penpulimab for Unresectable Hepatocellular Carcinoma

NCT07746960 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-05

No results posted yet for this study

Summary

The objective of this clinical trial study is to determine whether intravenous chemotherapy with the Ralox regimen in combination with Anlotinib and Penpulimab has certain efficacy and high safety for patients with unresectable hepatocellular carcinoma.

Overall design: This clinical study is a single - center, single - arm, prospective clinical study.

In this single - arm study, randomization grouping is not involved. Sample size estimation: According to previous research reports, the objective response rate (ORR0) of targeted immunotherapy for literature unresectable HCC is 30%. If α = 0.05 and 1 - β = 0.80 are set, and assuming that the ORR1 of systemic chemotherapy combined with targeted immunotherapy for unresectable HCC is 59.2%, at least 21 patients need to be enrolled as calculated by the PASS15.0 software. Considering a 10% dropout rate, 24 patients need to be enrolled. It is planned to enroll a total of 30 patients.

Subjects will receive systemic intravenous chemotherapy combined with immune checkpoint inhibitors and targeted drug therapy:

The intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1.

Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation.

Each cycle is 21 days. The combined medication will be continued for 3 cycles, or until obvious disease progression, patient intolerance, or until the researcher deems it necessary to stop the medication (whichever occurs first). After that, subsequent treatment will be carried out according to the clinical diagnosis and treatment routine based on the tumor situation.

For each subject, safety assessment and research compliance assessment will be conducted at the first dose and at Weeks 1, 2, and 3 of treatment, and the researcher will medication provide guidance. An examination will be conducted once at the screening visit, every 6 weeks during the treatment phase, and at each research visit during the follow - up period. Throughout the entire research process, its toxicity and safety will be monitored.

Conditions

  • Hepatocellular Carcinoma Non-Resectable

Interventions

DRUG

Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab

The intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1. Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-10-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07746960 on ClinicalTrials.gov