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NCT06015035

Sintilimab and Anlotinib Combined With Chemotherapy in Neoadjuvant Treatment of Resectable Esophageal Cancer

Completed Phase 2 Last updated 29 August 2023
What this trial tests

Phase 2 trial testing Sintilimab and anlotinib in combination with chemotherapy in Sintilimab and Anlotinib in Combination With Chemotherapy in 17 participants. Completed in 1 April 2022.

Timeline
1 April 2021
Primary endpoint
1 April 2022
1 April 2022

Quick facts

Lead sponsorTang-Du Hospital
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date1 April 2021
Primary completion1 April 2022
Estimated completion1 April 2022
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Tang-Du Hospital

Who can join

Adults 18 to 75, any sex, with Sintilimab and Anlotinib in Combination With Chemotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study focused on patients with T2-4NxM0 resectable esophageal carcinoma. Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for anti-angiogenesis and sintilimab (200 mg) and chemotherapyfor three cycles. Surgical treatment was performed 4-6 weeks after the last chemotherapy cycle was completed. The primary endpoints assessed were pathological complete response (pCR) rate and safety.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A prospective single-center, single-arm, open-label, phase II study of sintilimab and anlotinib combined with chemotherapy in neoadjuvant treatment of resectable esophageal cancer.
    Duan H, Wang Z, Cao L, Zhu Y, et al · · 2024 · cited 2× · PMID 38770548 · DOI 10.1111/1759-7714.15312

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Other Tang-Du Hospital trials

Trials by the same sponsor.

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Data sources for this page

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