A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma

Sponsor
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Study ID
NCT06656091
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Advanced Oesophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.

Key Dates

Start date
Oct 31, 2024
Status verified
Oct 2024
Primary completion
Jan 30, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: simmitinib
    simmitinib 6mg,QD ,3 weeks on 1 week off
  • Active Comparator: investigator's choice of chemotherapy
    docetaxel injection 75mg/m\^2,d1,every 3 weeks；or ilinotecan injection 180mg/m\^2,d1,every 2 weeks

Primary Outcome Measure

OS [ Time Frame: up to approximately 3 years ]

Central Contacts