OncoMatch/Clinical Trials/NCT07863141
A Phase II Study of Anlotinib + PD-1 Inhibitor vs. PD-1 Inhibitor Maintenance After First-Line Chemoimmunotherapy in Advanced ESCC (Esophageal Squamous Cell Carcinoma)
Official title: A Randomized, Multicenter, Open-label, Phase II Study of Maintenance Anlotinib Plus PD-1 Inhibitor Versus PD-1 Inhibitor Alone in Patients With Advanced Esophageal Squamous Cell Carcinoma Without Progression After First-line Chemoimmunotherapy
Is NCT07863141 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including anlotinib + PD-1 inhibitor and PD-1 inhibitor for esophageal cancer (ec).
Treatment: anlotinib + PD-1 inhibitor · PD-1 inhibitor — Chemotherapy combined with PD-1 inhibitor immunotherapy is the standard treatment for advanced esophageal squamous cell carcinoma (ESCC), yet patient prognosis remains unsatisfactory, with a median PFS of only about 6 months and a 1-year PFS rate of only 25%. Adding anlotinib maintenance therapy on top of PD-1 inhibitor immunotherapy maintenance after chemoimmunotherapy may improve progression-free survival and overall survival. We plan to conduct a randomized, multicenter, open-label Phase II study of anlotinib combined with PD-1 inhibitor maintenance therapy versus PD-1 inhibitor monotherapy maintenance in advanced ESCC. A total of 112 patients with unresectable locally advanced, recurrent, or metastatic ESCC are planned to be enrolled. After enrollment, patients will receive either anlotinib combined with PD-1 inhibitor maintenance therapy or PD-1 inhibitor monotherapy maintenance, with a maximum treatment duration of 2 years. This study aims to evaluate the efficacy and safety of anlotinib combined with PD-1 inhibitor maintenance therapy in advanced ESCC by comparing it with the PD-1 inhibitor monotherapy maintenance group, further optimizing the comprehensive treatment model for esophageal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: PD-1 inhibitor combined with platinum-based doublet chemotherapy — first-line for advanced ESCC
Patients who have completed 4-6 cycles of PD-1 inhibitor combined with platinum-based doublet chemotherapy, ... and who have not progressed after the above treatment
Cannot have received: anlotinib (anlotinib)
Prior treatment with anlotinib
Lab requirements
Blood counts
neutrophils ≥1.5×10^9/L, platelets ≥75.0×10^9/L, hemoglobin ≥80 g/L
Kidney function
serum creatinine ≤1.5 × ULN or creatinine clearance >60 mL/min
Liver function
total bilirubin ≤1.5 × ULN, ALT/AST ≤2.5 × ULN (≤5 × ULN if liver metastasis is present)
Cardiac function
LVEF <50% on echocardiography, severe/unstable angina, NYHA class III-IV heart failure, severe arrhythmia requiring pharmacological intervention, prior coronary/peripheral artery bypass grafting within 6 months before enrollment
Laboratory tests within 7 days before the first dose must meet the following requirements: Hematology: neutrophils ≥1.5×10^9/L, platelets ≥75.0×10^9/L, hemoglobin ≥80 g/L; Liver function: total bilirubin ≤1.5 × ULN, ALT/AST ≤2.5 × ULN (≤5 × ULN if liver metastasis is present); Renal function: serum creatinine ≤1.5 × ULN or creatinine clearance >60 mL/min; Coagulation function: INR or PT ≤1.5 × ULN; ... severe cardiovascular disease: myocardial infarction, severe/unstable angina, NYHA class III-IV heart failure, LVEF <50% on echocardiography, severe arrhythmia requiring pharmacological intervention, or prior coronary/peripheral artery bypass grafting within 6 months before enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07863141 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anlotinib disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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