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A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC

ConditionsAdvanced Esophageal Squamous Cell CarcinomaMetastatic Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of tislelizumab administered once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in combination with chemotherapy as first-line treatment in Japanese participants with previously untreated, unresectable locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide written informed consent by the participant or by the participants' legally acceptable representative and can understand and agree to comply with the requirements of the study

Histologically confirmed, unresectable locally advanced, recurrent or metastatic ESCC not amenable to curative approaches such as definitive chemoradiation or surgery.

No previous systemic therapy for unresectable locally advanced, recurrent or metastatic ESCC

At least 1 measurable lesion per RECIST v1.1 as determined by investigator

Disqualifiers

Participants who are unable to comply with the requirements of the protocol

Participants with evidence of esophageal or gastroesophageal perforation or fistula ( esophageal/bronchial or esophageal/aorta), or complete esophageal obstruction not amenable to treatment within 6 months prior to the first dose of study drugs

Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention) and/or diuretics within 7 days prior to the first dose of study drugs (the cytological confirmation of any effusion is permitted)

Have an estimated life expectancy < 3 months, per the judgment of the investigator

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    Administered by intravenous infusion

  • Oxaliplatin

    Drug

    Administered by intravenous infusion

  • Leucovorin

    Drug

    Administered by intravenous infusion

  • 5-fluorouracil (5-FU)

    Drug

    Administered by intravenous infusion

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm A: Tislelizumab Q2W + FOLFOX regimenExperimental treatment 4 interventions
Group B: Arm B: Tislelizumab Q4W + FOLFOX regimenExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Serum Concentrations of Tislelizumab at Specified Time Points

Time frame
Approximately 12 months
2

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAEv5.0) timing, seriousness, and relationship to study treatment

Time frame
Approximately 12 months
3

Overall Response Rate (ORR)Assessed by Independent Review Committee (IRC)

ORR is defined as the percentage of participants with partial or complete response, as assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
Approximately 12 months

Secondary outcomes

1

Progression-Free Survival (PFS) Rate at 6 Months

Six-month progression-free survival (PFS) rate, defined as the percentage of participants free from first documentation of disease progression assessed by the IRC using RECIST v1.1, or death, whichever comes first, for six months after first dose

Time frame
6 months

Other outcomes

Sponsors and contacts

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

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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