Description:
This is a randomized, double-blind multi-center, phase III study comparing the efficacy and
safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in
subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell
carcinoma.
Title
- Brief Title: Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma
- Official Title: A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)
Clinical Trial IDs
- ORG STUDY ID:
CIBI308A301
- NCT ID:
NCT03748134
Conditions
- Esophageal Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Sintilimab | | Sintilimab + chemotherapy |
Placebo | | Placebo + chemotherapy |
Cisplatin | | Placebo + chemotherapy |
Paclitaxel | | Placebo + chemotherapy |
Fluorouracil | | Placebo + chemotherapy |
Purpose
This is a randomized, double-blind multi-center, phase III study comparing the efficacy and
safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in
subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell
carcinoma.
Trial Arms
Name | Type | Description | Interventions |
---|
Sintilimab + chemotherapy | Experimental | Sintilimab in combination with investigator's choice of chemotherapy
TP regimen: Cisplatin + paclitaxel
or
CP regimen: Cisplatin + fluorourcil | - Sintilimab
- Cisplatin
- Paclitaxel
- Fluorouracil
|
Placebo + chemotherapy | Active Comparator | Placebo in combination with investigator's choice of chemotherapy
TP regimen: Cisplatin + paclitaxel
or
CP regimen: Cisplatin + fluorourcil | - Placebo
- Cisplatin
- Paclitaxel
- Fluorouracil
|
Eligibility Criteria
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
chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or
definitive chemotherapy/radiochemotherapy, time from the completion of last treatment
to disease recurrence must be > 6 months Could provide archival or fresh tissues for
PD-L1 expression analysis with obtainable results#
- Have at least one measurable lesion as per RECIST v1.1
Key exclusion Criteria:
- ESCC with endoscopy-confirmed near-complete obstruction requiring interventional
therapy
- Post stent implantation in the esophagus or trachea with risk of perforation
- Received systemic treatment for advanced or metastatic ESCC.
- Received a Cumulative dose of cisplatin > 300 mg/m2 within 12 months to randomization.
- High risk of hemorrhage or perforations due to tumor invasion in adjacent organs
(aorta or trachea), or have fistula formation.
- Hepatic metastasis > 50% of the total liver volume.
- Received palliative therapy for a local lesion within 2 weeks prior to the first dose.
- Received systemic treatment with Chinese traditional medicines with anti-cancer
indications or immunomodulators (including thymosins, interferons, and interleukins)
within 2 weeks prior to the first dose of study treatment.
- Received systemic immunosuppressants within 2 weeks prior to randomization, excluding
local use of glucocorticoids administered by nasal, inhaled, or other routes, and
systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone
or equivalents), or glucocorticoids to prevent allergies to contrast media.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | OS in overall population |
Time Frame: | From date of randomization until the date of death from any cause, assessed up to 40 months. |
Safety Issue: | |
Description: | 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) |
Secondary Outcome Measures
Measure: | ORR in overall population |
Time Frame: | From date of randomization up to 28 months. |
Safety Issue: | |
Description: | To compare the objective response rate between the two treatment arms in ITT population |
Measure: | PFS in overall populationsubjects in ITT population |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the progression-free survival between the two treatment arms in ITT population |
Measure: | DCR in overall population |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the disease control rate between the two treatment arms in ITT population |
Measure: | DoR in overall population |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the duration of response between the two treatment arms in ITT population |
Measure: | ORR - PD-L1 positive |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the objective response rate between the two treatment arms in PD-L1 positive subjects in ITT population |
Measure: | DCR - PD-L1 positive |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the disease control rate between the two treatment arms in PD-L1 positive subjects in ITT population |
Measure: | DoR - PD-L1 positive |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the duration of response between the two treatment arms in PD-L1 positive subjects in ITT population |
Measure: | PFS - PD-L1 positive |
Time Frame: | From date of randomization up to 28 months |
Safety Issue: | |
Description: | To compare the progression-free survival between the two treatment arms in PD-L1 positive subjects in ITT population |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Innovent Biologics (Suzhou) Co. Ltd. |
Trial Keywords
- ESCC
- Esophageal Cancer
- Esophageal Neoplasms
- Esophageal Neoplasms Malignant
- Esophageal Squamous Cell Carcinoma
- Neoplasms, Squamous Cell
- Esophageal Diseases
- Carcinoma, Squamous Cell
- Gastrointestinal Diseases
- Paclitaxel
- Cisplatin
- Fluorouracil
- Antineoplastic Agents
- Anti-PD-1
- Sintilimab
Last Updated
August 2, 2021