A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or … (NCT06304974) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus01)
China497 participantsStarted 2024-03-19
Plain-language summary
This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent and follow the requirements of the protocol;
✓. Age ≥18 years old;
✓. Expected survival time ≥3 months;
✓. Patients with recurrent or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology;
✓. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
✓. Must have at least one measurable lesion according to RECIST v1.1 definition;
✓. ECOG 0 or 1;
✓. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
Exclusion criteria
✕. Chemotherapy, targeted therapy, biological therapy, etc., had been used within 4 weeks or 5 half-lives before randomization, and palliative radiotherapy and modern traditional Chinese medicine preparations approved by NMPA had been used within 2 weeks;
✕. Patients with recurrent esophageal squamous cell carcinoma suitable for radical local treatment should be excluded;
✕. Frontline received ADCs with topoisomerase I inhibitors as toxins;
✕. History of severe heart disease and cerebrovascular disease;