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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unlimited RT and PD-1 inhibitor maintenance therapy | Experimental | Unlimited radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy. |
|
| Unlimited RT and surveillance | Active Comparator | Unlimited radiotherapy 50.4Gy/28Fx. |
|
| TDLN-sparing RT and PD-1 inhibitor maintenance therapy | Experimental | TDLN-sparing radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy. |
|
| TDLN-sparing RT and surveillance | Experimental | TDLN-sparing radiotherapy 50.4Gy/28Fx. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS for TDLN-sparing RT followed by PD-1 inhibitor maintenance therapy vs TDLN-sparing RT followed by surveillance | 2 years |
| OS | OS for TDLN-sparing RT followed by PD-1 inhibitor maintenance therapy vs TDLN-sparing RT followed by surveillance |
| Measure | Description | Time Frame |
|---|---|---|
| biomarker analysis | PD-L1 subgroup analysis | 2 years |
Inclusion Criteria:
7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN
Exclusion Criteria:
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.
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.
Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuaile Zhao, MD | Contact | +86-21-64175590 | kuaile_z@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| C111043 | TP protocol |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| 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 |
|
| 2 years |
| OS | OS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance | 2 years |
| Adverse events | up to 2 years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |