a study comparing bl-b01d1 with chemotherapy of physician's choice in patients with recurrent or metastatic esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

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.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent and follow the requirements of the protocol; 2. age ≥18 years old; 3. expected survival time ≥3 months; 4. patients with recurrent or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology; 5. consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years; 6. must have at least one measurable lesion according to recist v1.1 definition; 7. ecog 0 or 1; 8. toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 9. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 10. 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; 11. urine protein ≤2+ or \< 1000mg/24h; 12. 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: 1. 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; 2. patients with recurrent esophageal squamous cell carcinoma suitable for radical local treatment should be excluded; 3. frontline received adcs with topoisomerase i inhibitors as toxins; 4. history of severe heart disease and cerebrovascular disease; 5. prolonged qt interval, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 6. diagnosed with active malignancy within 3 years before randomization; 7. hypertension poorly controlled by two antihypertensive drugs; 8. patients with poor glycemic control; 9. 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; 10. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 11. patients with active central nervous system metastases; 12. severe infections within 4 weeks before randomization; evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; 13. patients with massive or symptomatic effusions or poorly controlled effusions; 14. imaging examination showed that the tumor had invaded or wrapped around the large blood vessels in the abdomen, chest, neck, and pharynx; 15. serious unhealed wounds, ulcers, or fractures, or clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 16. patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction or chronic diarrhea; 17. patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of bl-b01d1; 18. had a history of autologous or allogeneic stem cell transplantation; 19. human immunodeficiency virus antibody positive, active hepatitis b virus infection or hepatitis c virus infection; 20. a history of severe neurological or psychiatric illness; 21. received other unmarketed investigational drugs or treatments within 4 weeks before randomization; 22. subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization; 23. other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.