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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony patologicznie rak płaskonabłonkowy przełyku
- •Zaawansowana postać raka (nie do operacji, przerzuty) bez wcześniejszego leczenia, lub wznowa po więcej niż 6 miesiącach
- •Ukończone 4-6 cykli chemioterapii z immunoterapią bez progresji choroby
- •Wiek 18-75 lat
- •Ogólny stan zdrowia pozwalający na leczenie (skala ECOG 0-1)
- •Wyniki badań laboratoryjnych w normie (morfologia, wątroba, nerki, krzepnięcie)
- •Spodziewana długość życia ponad 3 miesiące
- •Podpisana świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Uczulenie na leki stosowane w badaniu
- •Możliwość wyleczenia operacją lub radioterapią
- •Głębokie owrzodzenia lub przerwanie przełyku wymagające zabiegu
- •Napaśnięcie przez nowotwór żył głównych lub tchawicy ze wysokim ryzykiem krwawienia
- •Przetoka przełykowa (połączenie z tchawicą lub osierdiem)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- October 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Trial contact
Yong Bao, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/8/2026.
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