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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
. 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;