This is a single-arm, Simon's two-stage phase II clinical trial to evaluate the efficacy and safety of QL1706 (a dual PD-1 and CTLA-4 antibody) combined with celecoxib in patients with advanced esophageal squamous cell carcinoma (ESCC) who progressed after prior immune checkpoint inhibitor therapy.
The study aims to explore whether the combination of QL1706 and celecoxib can improve the objective response rate in ICI-refractory ESCC. Eligible patients will receive QL1706 (5 mg/kg IV Q3W) and celecoxib (200 mg BID orally) until disease progression, unacceptable toxicity, or up to 2 years. Safety, PFS, OS, and biomarkers such as PD-L1, HER2, IL-6, and IL-8 will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
QL1706 (anti-PD-1/CTLA-4 bispecific antibody) will be administered at 5 mg/kg by intravenous infusion every 3 weeks. Celecoxib 200 mg will be taken orally twice daily starting on Day 1 of each 3-week treatment cycle. Treatment continues until disease progression, intolerable toxicity, or for a maximum of 2 years.
Objective Response Rate (ORR) as assessed by RECIST v1.1
Objective Response Rate (ORR) per RECIST v1.1 at 6 months
Time frame: Up to 24 weeks from first dose
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) defined as the time from the first dose to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: 1 year
Overall Survival (OS)
Overall Survival (OS) defined as the time from the first dose to death from any cause.
Time frame: 1 year
Duration of Response (DOR)
Duration of Response (DOR) for participants who achieve a complete response (CR) or partial response (PR), measured from the first documented response until documented disease progression per RECIST v1.1 or death.
Time frame: 1 year
Time to Response (TTR)
Time to Response (TTR) defined as the time from the first dose to the first documented objective response (CR or PR) per RECIST v1.1.
Time frame: 1 year
Disease Control Rate (DCR)
Disease Control Rate (DCR) defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v1.1.
Time frame: 1 year
Safety Assessment
Incidence and severity of adverse events as assessed by CTCAE v5.0.
Time frame: 1 year
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