A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemot… (NCT07554456) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)
China90 participantsStarted 2026-04
Plain-language summary
This trial is a registrational Phase II/III, randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with tislelizumab ± 5-FU in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent form and agree to follow the protocol requirements;
✓. No gender restriction;
✓. Age ≥18 years and ≤75 years at the time of signing the informed consent form;
✓. Expected survival time ≥3 months;
✓. Patients with unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;
✓. Must have at least one measurable target lesion as defined by RECIST v1.1;
✓. Must provide archived tumor tissue specimens from the primary or metastatic lesion within the past 3 years;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Exclusion criteria
✕. Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;
✕. Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;
✕. Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;
✕. Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;