Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma

Sponsor
Peking University
Study ID
NCT02645864
Phase
PHASE1
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    250mg p.o. qd in first cohort (3 subjects). 250mg p.o. bid in second cohort (3 subjects) 250mg p.o. tid in third cohort (3 subjects)
  • Irinotecan — DRUG
    150mg/m\^2 i.v. q2w

Study Details

Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant pathological type in China and account for more than 95% cases in clinic. The prognosis of ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse in many patients. For patients with unresectable or recurrent disease, chemotherapy is an important treatment alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is still no standard 2nd-line treatment for patients who fail in first-line treatment. Both irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients. But there are only a few of ESCC patients involved in those studies. Except for chemotherapy, targeting treatment is another promising treatment for esophageal cancer. In recent years, antiangiogenic treatment has been proved to be effective and tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has shown that it is effective in the treatment of a variety of solid tumors including esophageal cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators initialize this dose escalation phase I study to explore the safety of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.

Key Dates

Start date
Jan 31, 2016
Status verified
Apr 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib and Irinotecan
    This study will include a sequential evaluation of 3 subjects per cohort. Cohort 1: apatinib 250 mg per day and irinotecan 150mg q2w. Cohort 2: apatinib 500 mg per day and irinotecan 150mg q2w. Cohort 3: apatinib 750 mg per day and irinotecan 150mg q2w. A dose limiting toxicity (DLT) event is defined as any of the following events: * CTCAE Grade 4 event * Grade 3 non-hematologic toxicity including fever, nausea, vomiting, and diarrhea that continues despite optimal medical management) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If two (2) DLTs are experienced in any cohort, the study will stop and the dose of combination treatment in this cohort will be documented.

Primary Outcome Measure

Dose limiting toxicity [ Time Frame: From enrollment to 1 months after completion of treatment. Estimated about 3 months. ]

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