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A Study of BL-B01D1 in Combination With Tislelizumab ±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)

ConditionEsophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Patients with esophageal squamous cell carcinoma whose pathology indicates the presence of non-squamous carcinoma components;

Use of immunomodulatory drugs within 2 weeks prior to the first study drug administration;

Prior use of an ADC drug whose small-molecule toxin is a topoisomerase I inhibitor;

Patients with esophageal squamous cell carcinoma who are suitable for curative-intent local therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-B01D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Tislelizumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • 5-Fluorouracil

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Cisplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Paclitaxel

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: BL-B01D1 + tislelizumab + 5-FUExperimental treatment 3 interventions
Group B: BL-B01D1 + tislelizumabExperimental treatment 2 interventions
Group C: cisplatin + paclitaxel/5-FU+ tislelizumabActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

Time frame
Up to approximately 24 months
2

Disease Control Rate (DCR)

Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

Time frame
Up to approximately 24 months
3

Duration of Response (DOR)

Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

Time frame
Up to approximately 24 months
4

Progression-free survival (PFS)

Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: