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Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma

RECRUITINGPhase 2Sponsored by Fudan University
Actively Recruiting
PhasePhase 2
SponsorFudan University
Started2023-12-01
Est. completion2024-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* Be willing and able to provide written informed consent/assent for the trial.
* Males or unpregnant females who age ≥ 18 years, ≤75 years.
* The investigator believes the patient is capable of complying with the study protocol.
* Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma.
* is not a candidate for radical surgery
* not received previous systemic treatment
* patients must have at least one measurable lesion (RECIST 1.1)
* ECOG PS:0-1, 14 days before enrollment
* Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment

Exclusion Criteria:

* Prior history of other malignant tumors
* Current or prior immunodeficiency disorders or autoimmune diseases
* Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding
* Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study
* Conditions considered unsuitable for inclusion by researchers

Conditions4

CancerHepatocellular CarcinomaLiver CancerLiver Disease

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