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TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC

ConditionsEsophageal CarcinomaRadiotherapyImmunotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

The goal of this clinical trial is to learn if immunotherapy in combination with tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) and chemotherapy works to treat locally advanced esophageal squamous cell cancer in adults.

Researchers will compare immunotherapy in combination with TDLN-sparing RT and chemotherapy to TDLN-sparing RT and chemotherapy to see if immunotherapy works more effectively when using TDLN-sparing RT to treat locally advanced esophageal squamous cell cancer

Participants will:

TDLN-sparing RT for esophageal cancer 50.4Gy/28Fx Paclitaxel plus cisplatin every 3 weeks for 4 cycles PD-1 inhibitors or observation every 3 weeks for 1 year

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Aged 18-75 years

Histologically confirmed esophageal squamous cell carcinoma

Clinical stages T2-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes metastasis) based on the 8th UICC-TNM classification

Disqualifiers

Esophageal perforation or hematemesis

Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).

Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection.

Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunotherapy

    Drug

    PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.

  • chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens

    Drug

    Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles. or other guideline recommended regimens

  • TDLN-sparing RT

    Radiation

    TDLN-sparing radiotherapy 50.4Gy/28Fx.

Treatment groups

432 Participants
are divided into 2 treatment groups
Group A: Concurrent Immunotherapy plus TDLN-sparing RT and ChemotherapyExperimental treatment 3 interventions
Group B: TDLN-sparing RT and ChemotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

PFS for patients with TDLN V15 ≤ 50%

Time frame
2 years
2

PFS for all patients

Time frame
2 years

Secondary outcomes

1

OS for patients with TDLN V15 ≤ 50%

Time frame
2 years
2

OS for all patients

Time frame
2 years
3

Adverse events

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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