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A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This trial is a registrational Phase II/III, randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with tislelizumab ± 5-FU in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Voluntarily sign the informed consent form and agree to follow the protocol requirements;

• No gender restriction;

• Age ≥18 years and ≤75 years at the time of signing the informed consent form;

• Expected survival time ≥3 months;

• Patients with unresectable, locally advanced recurrent or metastatic first-line esophageal squamous cell carcinoma;

• Must have at least one measurable target lesion as defined by RECIST v1.1;

• Must provide archived tumor tissue specimens from the primary or metastatic lesion within the past 3 years;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;

⁃ No severe cardiac dysfunction; left ventricular ejection fraction ≥50%;

⁃ Organ function levels must meet the specified requirements;

⁃ Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);

⁃ Urine protein ≤1+ or \<1000 mg/24h;

⁃ For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must be negative, and the patient must not be breastfeeding; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2026-06-09
Estimated Completion Date: 2028-12
Participants
Target number of participants: 90
Treatments
Experimental: BL-B01D1 + tislelizumab + 5-FU
Participants receive BL-B01D1 + tislelizumab + 5-FU in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Experimental: BL-B01D1 + tislelizumab
Participants receive BL-B01D1 + tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Active_comparator: cisplatin + paclitaxel/5-FU+ tislelizumab
Participants receive cisplatin + paclitaxel/5-FU+ tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Related Therapeutic Areas
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov