QL1706 As Second-line Treatment in Patients with Advanced Hepatocellular Carcinoma

NCT06822985 | Not Yet Recruiting Phase 1

• 1 other identifier: QLMA-HCC-IIT-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I trial to assess the safety and preliminary efficacy of QL1706 in Treating Advanced Hepatocellular Carcinoma Patients refractory to prior immunotherapy.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

QL1706; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival(mPFS)

  measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.

  From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year

Secondary Outcomes (4)

• overall response rate (ORR) measured by mRECIST criteria

  rom the date of first treatment to radiographically documented progression according to mRECIST, assessed up to 2 year

• Overall survival (OS)

  from the date of first treatment to the date of death from any cause, assessed up to 2 year

• Disease control rate (DCR)

  from the date of first treatment to radiographically documented response according to mRECIST, assessed up to 2 year

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 21 days post-the last treatment

Study Arms (1)

Experimental: QL1706

EXPERIMENTAL

Drug: QL1706

Drug: QL1706

Interventions

QL1706 DRUG

Drug: QL1706 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

Experimental: QL1706

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects participate voluntarily and sign informed consent.
• years ≤ age ≤ 75 years;
• Child-Pugh liver function score ≤ 7;
• ECOG PS 0-1;
• No serious organic diseases of heart, lung, brain, kidney and other organs;
• Enhanced MRI examination confirmed advanced hepatocellular carcinoma (CNLC stage II and above, Barcelona stage B and above);
• Puncture biopsy confirming the pathologic type as hepatocellular carcinoma;
• Disease progression after receiving first-line therapy(Progressed on/relapsed after at least one prior anti-PD-1 treatment).

You may not qualify if:

• Pregnant and lactating women;
• Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
• A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood of ++ or more, or gastroscopy if persistent fecal occult blood of +) that has not been treated in a targeted manner, or any other condition that may have caused gastrointestinal bleeding (e.g., severe fundal/esophageal varices) as determined by the investigator;
• Active infections, including: HIV (HIV1/2 antibody) positive; active hepatitis B (HBsAg positive and abnormal liver function); active hepatitis C (HCV antibody positive or HCV RNA ≥103 copies/ml and abnormal liver function); active tuberculosis; and other uncontrolled active infections (CTCAE V5.0 \>2 level);
• Other significant clinical and laboratory abnormalities that, in the opinion of the investigator, affect the safety evaluation, e.g., uncontrolled diabetes mellitus, immunodeficiency disorders, chronic kidney disease, grade II or higher peripheral neuropathy (CTCAE V5.0), and abnormal thyroid function;
• Prior use of anti-CTLA-4 antibody drugs.
• Inability to follow the study protocol to receive treatment or follow up as scheduled.

Sponsors & Collaborators

• Wan-Guang Zhang: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

WanGuang Zhang WanGuang Zhang

CONTACT

13886195965; wgzhang@tjh.tjmu.edu.cn

Xiaoping Chen Xiaoping Chen

CONTACT

02783663400; chenxpchenxp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)