Retlirafusp Alfa Combined With Chemoradiotherapy in Unresectable ESCC

ConditionEsophageal Squamous Cell Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorRenJi Hospital

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the written informed consent form and agree to participate in this study;

Pathologically confirmed esophageal squamous cell carcinoma;

Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition);

Aged 18-75 years, male or female;

Disqualifiers

Any prior or ongoing radiotherapy, chemotherapy, or other anti-tumor agents for malignancy;

Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at a dose > 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids, and adrenal hormone replacement at doses > 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease;

Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug;

Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;

Trial design

Design model

Single group

Treatments tested in this trial

Induction chemo-immunotherapy
Drug
Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy: Retlirafusp alfa 1800mg Day1 + Albumin-bound paclitaxel 125mg/m² Day 1 and Day 8 + Cisplatin 25mg/m² Day 1-3 every 3 weeks (Q3w)
Concurrent chemoradiotherapy (cCRT)
Radiation
Radiation: 1.8Gy/Fx, total dose (DT) 50.4Gy/28Fx; Chemotherapy: Albumin-bound paclitaxel 60-80mg/m² + Cisplatin 25mg/m² Day 1 every week (Qw)
maintenance immunotherapy
Drug
Retlirafusp Alfa 1800 mg on Day 1, Q3W, as maintenance therapy until disease progression or unacceptable toxicity, for up to 1 year; the total number of cycles for Retlirafusp Alfa induction and maintenance therapy should not exceed 15 cycles.

Treatment groups

68 Participants

are divided into 1 treatment group

Group A: Retlirafusp Alfa Combined With ChemoradiotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1 year progression-free survival (PFS) rate

Progression-free survival (PFS) is defined as the time from the date of first study treatment administration to the first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)) or death from any cause, whichever occurs first. The 1-year PFS rate is the proportion of participants who are alive and progression-free at 1 year (12 months) after the first dose.

Time frame

From the date of first study treatment administration until the date of first documented progression or death from any cause, whichever comes first, assessed up to 1 year (12 months).

Sponsors and contacts

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

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

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