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Trial Title:
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06304974
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Docetaxel
Irinotecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion
Arm group label:
Experimental Group
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Administration by intravenous infusion
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
Administration by intravenous infusion
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
docetaxel
Description:
Administration by intravenous infusion
Arm group label:
Control group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen
Start date:
March 19, 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304974