Efficacy and Safety of Anlotinib Hydrochloride Combined With Nivolumab in the Treatment of Gastric and Esophageal Cancer

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04503967
Phase
PHASE2
Status
Unknown

Conditions

  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma

Eligibility Criteria

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

Interventions

Study Details

Patients with unresectable or metastatic gastric or esophageal cancer, with first-line treatment applied are to be recruited in the study. In the current study, the efficacy and safety of anlotinib hydrochloride combined with nivolumab as second-line or salvage chemotherapy will be evaluated in Chinese patients with advanced gastric adenocarcinoma and esophageal squamous cell carcinoma. 48 patients could provide adequate precision rather than controlling type I\&II error.

Key Dates

Start date
Aug 1, 2020
Status verified
Aug 2020
Primary completion
Feb 1, 2021
Completion
Aug 1, 2021

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib Hydrochloride With Nivolumab
    Anlotinib Hydrochloride Combined With Nivolumab in the second line treatment of Gastric and Esophageal Cancer patients

Primary Outcome Measure

Objective response rate [ Time Frame: up to 2 years ]

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