Clinical Trials /

Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma

NCT03748134

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.

Related Conditions:
  • Esophageal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
SintilimabSintilimab + chemotherapy
PlaceboPlacebo + chemotherapy
CisplatinPlacebo + chemotherapy
PaclitaxelPlacebo + chemotherapy
FluorouracilPlacebo + 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

NameTypeDescriptionInterventions
Sintilimab + chemotherapyExperimentalSintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil
  • Sintilimab
  • Cisplatin
  • Paclitaxel
  • Fluorouracil
Placebo + chemotherapyActive ComparatorPlacebo 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

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

July 16, 2020