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Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

NCT06426797 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-23

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are:

What level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity?

Participants will:

Receive cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles.

Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication.

Accept an follow-up for 2 years after surgery.

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Cadonilimab plus anlotinib

cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles

Sponsors & Collaborators

  • Akeso Pharmaceuticals, Inc.

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Fan Yang, M.D. · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-05-31
Completion
2027-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426797 on ClinicalTrials.gov