CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC
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
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
Treatments tested in this trial
- PD-1 inhibitor
- Unlimited radiotherapy
- TP regimen
- TDLN-sparing radiotherapy
Treatment groups
452 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov