Clinical trial · Interventional
QL1706 As Second-line Treatment in Patients with Advanced Hepatocellular Carcinoma
The Efficacy and Safety of QL1706 As Second-line Treatment in Advanced Hepatocellular Carcinoma Patients Refractory to First-line Therapy: a Single-arm, Phase I Study
NCT06822985CI-TRIAL-00085901QL1706not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC - Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: QL1706
- description
- Drug: QL1706
- interventionNames
- Drug: QL1706
Primary outcomes (1)
- measure
- Median progression-free survival(mPFS)
- timeFrame
- From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year
- description
- 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.
Secondary outcomes (4)
- measure
- overall response rate (ORR) measured by mRECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects participate voluntarily and sign informed consent. 2. 18 years ≤ age ≤ 75 years; 3. Child-Pugh liver function score ≤ 7; 4. ECOG PS 0-1; 5. No serious organic diseases of heart, lung, brain, kidney and other organs; 6. Enhanced MRI examination confirmed advanced hepatocellular carcinoma (CNLC stage II and above, Barcelona stage B and above); 7. Puncture biopsy confirming the pathologic type as hepatocellular carcinoma; 8. Disease progression after receiving first-line therapy(Progressed on/relapsed after at least one prior anti-PD-1 treatment). Exclusion Criteria: 1. Pregnant and lactating women; 2. 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.); 3. 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; 4. 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); 5. 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; 6. Prior use of anti-CTLA-4 antibody drugs. 7. Inability to follow the study protocol to receive treatment or follow up as scheduled.
References
Publications (0)
Data not yet available
No reference posted for this study.