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Sintilimab · 1 trial · 1 indication
To compare the overall survival of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
To compare the OS of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with PD-L1 positive, unresectable, locally advanced, recurrent or metastatic ESCC
| Arm | Type | Description |
|---|---|---|
| Randomized Part: Experimental: Sintilimab + chemotherapy | EXPERIMENTAL | Sintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil |
| Randomised Part: Active Comparator: Placebo + chemotherapy | ACTIVE_COMPARATOR | Placebo in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil |
| Open-label part: Sintilimab+ chemotherapy | EXPERIMENTAL | Sintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil |
| Name | Type | Description |
|---|---|---|
| Sintilimab | BIOLOGICAL | For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 |
| Cisplatin | DRUG | 75mg/m\^2 IV Q3W day 1 |
| Paclitaxel | DRUG | 87.5 mg/m\^2 IV Q3W day 1, day 8 for first cycle and 175mg/m\^2 IV Q3W day 1 after first cycle |
| Fluorouracil | DRUG | 800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W |
| Placebo | DRUG | For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 |
Key Inclusion Criteria: * Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic ESCC (excluding mixed adenosquamous carcinoma and other histological subtypes) * ECOG PS of 0 or 1 * Subject must be unsuitable for definitive treatment, such as definitive chemoradiother...