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NCT07531979

Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2

Not yet recruiting Phase 2 Last updated 15 April 2026
What this trial tests

Phase 2 trial testing Tislelizumab in ESCC in 93 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
31 March 2027
31 December 2029

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment93
Start date1 April 2026
Primary completion31 March 2027
Estimated completion31 December 2029
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

18 and older, any sex, with ESCC or Tislelizumab. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. In recent years, immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 antibodies) combined with chemotherapy have become the standard first-line treatment for advanced ESCC. Multiple randomized controlled trials have confirmed that this combination significantly improves patient survival compared to chemotherapy alone. However, a subset of patients still exhibit poor response or develop resistance to the immunotherapy-chemotherapy regimen, necessitating the exploration of novel combination strategies to further enhance efficacy. The epidermal growth factor receptor (EGFR) is frequently overexpressed in ESCC and is associated with tumor proliferation, metastasis, and poor prognosis, making it an important therapeutic target. Antibody-drug conjugates (ADCs) targeting EGFR achieve precise tumor killing by conjugating an anti-EGFR antibody to a potent cytotoxic payload. Preclinical studies have demonstrated significant antitumor activity of EGFR ADCs in ESCC models. Mechanistically, anti-EGFR therapy and immune checkpoint inhibitor therapy may exert synergistic effects through several avenues: enhancing tumor antigen presentation, remodeling the tumor microenvironment, and modulating PD-L1 expression. Therefore, this triple combination strategy holds promise for overcoming the limitations of monotherapies and providing a new treatment option for patients with ESCC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Tislelizumab

Trials testing the same drug.

Other recruiting trials for ESCC

Currently open trials in the same condition.

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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