CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

ConditionsEsophageal Carcinoma Radiotherapy Immunotherapy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorFudan University

About this trial

The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Aged 18 years or above

Histologically confirmed esophageal squamous cell carcinoma

Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) 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).

Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.

Allergic to any of the ingredients in PD-1 inhibitors for injection.

Trial design

Design model

Parallel

Treatments tested in this trial

PD-1 inhibitor
Drug
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.
Unlimited radiotherapy
Radiation
Unlimited radiotherapy 50.4Gy/28Fx
TP regimen
Drug
Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d
TDLN-sparing radiotherapy
Radiation
Tumor draining lymph nodes-sparing radiotherapy 50.4Gy/28Fx

Treatment groups

452 Participants

are divided into 4 treatment groups

Group A: Unlimited RT and PD-1 inhibitor maintenance therapyExperimental treatment 3 interventions

Group B: Unlimited RT and surveillanceActive comparator 2 interventions

Group C: TDLN-sparing RT and PD-1 inhibitor maintenance therapyExperimental treatment 3 interventions

Group D: TDLN-sparing RT and surveillanceExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

PFS

PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance

Time frame

2 years

Secondary outcomes

PFS

PFS for TDLN-sparing RT followed by PD-1 inhibitor maintenance therapy vs TDLN-sparing RT followed by surveillance

Time frame

2 years

OS for TDLN-sparing RT followed by PD-1 inhibitor maintenance therapy vs TDLN-sparing RT followed by surveillance

Time frame

2 years

OS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance

Time frame

2 years

Adverse events

Time frame

up to 2 years

Other outcomes

biomarker analysis

PD-L1 subgroup analysis

Time frame

2 years

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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