A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Status: Not yet recruiting

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.

Eligibility:
- EligibilityCriteria: 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; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; No blood transfusion and no use of any cell growth factor drugs were allowed within 14 days before randomization, and the level of organ function had to be adequate; Urine protein ≤2+ or < 1000mg/24h; A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women who are likely to have children, and the result must be negative and must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.  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; Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; diagnosed with active malignancy within 3 years before randomization; Hypertension poorly controlled by two antihypertensive drugs; patients with poor glycemic control; present with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; A previous history of interstitial lung disease (ILD) or a suspicion of such disease on imaging during screening; Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; patients with active central nervous system metastases; Severe infections within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; patients with massive or symptomatic effusions or poorly controlled effusions; Imaging examination showed that the tumor had invaded or wrapped around the large blood vessels in the abdomen, chest, neck, and pharynx; serious unhealed wounds, ulcers, or fractures, or clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction or chronic diarrhea; patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1; had a history of autologous or allogeneic stem cell transplantation; Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection; a history of severe neurological or psychiatric illness; received other unmarketed investigational drugs or treatments within 4 weeks before randomization; subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization; Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult