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Becotatug Vedotin Plus Tislelizumab and Low-Dose Lenvatinib for Advanced Esophageal Squamous Cell Carcinoma, Phase II

NCT07686926 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-07-16

No results posted yet for this study

Summary

Immunotherapy combined with chemotherapy has become the first-line standard of care for advanced esophageal squamous cell carcinoma (ESCC), significantly improving patient survival. However, with the widespread adoption of first-line immunotherapy, most patients eventually develop immune resistance. After first-line treatment failure, there is currently no established standard effective therapy for second-line ESCC. Therefore, more effective and safer treatment options are urgently needed for second-line advanced ESCC.

This is a prospective, single-arm, single-center, open-label, Phase II clinical study aiming to evaluate the efficacy and safety of Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib in patients with advanced ESCC who have failed first-line therapy. Eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety.

Conditions

Interventions

DRUG

Becotatug Vedotin

Becotatug Vedotin 2.0 mg/kg administered as an intravenous infusion on Day 1 of each 21-day cycle for 4 to 6 cycles.

DRUG

Tislelizumab

Tislelizumab 200 mg administered as an intravenous infusion on Day 1 of each 21-day cycle, continued for up to 35 cycles (approximately 2 years), or until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first.

DRUG

Lenvatinib

Low-Dose Lenvatinib 4 mg administered orally at a fixed time once daily, continued until disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue, or study termination, whichever occurs first.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-07-31
Completion
2029-12-31

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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 NCT07686926 on ClinicalTrials.gov