TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC
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
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
Treatments tested in this trial
- Immunotherapy
- chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens
- TDLN-sparing RT
Treatment groups
432 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov