Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02645864|
Recruitment Status : Unknown
Verified April 2017 by Xiaodong Zhang, Peking University.
Recruitment status was: Recruiting
First Posted : January 5, 2016
Last Update Posted : April 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Drug: Apatinib Drug: Irinotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apatinib and Irinotecan Combination as Second-line Treatment in Esophageal Squamous Cell Carcinoma: a Phase I Dose Escalation Study|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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:
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)
Other Name: YN968D1
150mg/m^2 i.v. q2w
Other Name: Camptosar, Campto
- Dose limiting toxicity [ Time Frame: From enrollment to 1 months after completion of treatment. Estimated about 3 months. ]Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.0 criteria.
- Maximum tolerance dose [ Time Frame: From enrollment to 1 months after completion of treatment. Estimated about 3 months. ]Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.
- Objective response rate [ Time Frame: From enrollment to 3 months after treatment ]Definition of ORR: clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).
- Progression-free survival [ Time Frame: From enrollment to progression of disease. Estimated about 6 months. ]Definition of PFS: The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
- Overall survival [ Time Frame: From enrollment to death of patients. Estimated about 1 year. ]Definition of OS: The length of time from enrollment until the time of death (OS, overall survival).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645864
|Contact: Xiaodong Zhangfirstname.lastname@example.org|
|Contact: Xiaodong Zhangemail@example.com|
|Peking University Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Xiaodong Zhang 86-10-88196961 firstname.lastname@example.org|
|Principal Investigator: Xiaodong Zhang|
|Principal Investigator:||Xiaodong Zhang||Beijing Cancer Hospital|