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Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

ConditionImmunotherapy Esophagus Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFuzhou General Hospital

About this trial

To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;

Aged 18-70, both sexes;

ECOG score 0-1

The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;

Disqualifiers

A history of fistula caused by primary tumor invasion;

Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);

Known intolerance or resistance to chemotherapy specified in the trial protocol;

have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

  • Albumin paclitaxel

    Drug

    Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks

  • Nedaplatin

    Drug

    Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks

  • radiotherapy

    Radiation

    50-60Gy/25-30f

Treatment groups

93 Participants
are divided into 1 treatment group
Group A: Tislelizumab combined with chemothapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

progression free survival

Time from enrollment to the onset of disease progression or death

Time frame
up to 24 months

Secondary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

Time frame
every 6 weeks （up to 24 months）
2

Overall survival (OS)

Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up.

Time frame
every 3 months (up to 24 months)

Other outcomes

Sponsors and contacts

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

Fuzhou General Hospital

Lead sponsor

Source ClinicalTrials.gov
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