A phase I dose escalation study of Apatinib in combination with concurrent chemoradiation for patients with locally advanced squamous cell carcinoma of esophagus

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OIN-16007866
• Date of registration: 2016-01-31
• Prospective Registration: Yes
• Primary sponsor: Secondly Hospital, Shanxi Medical University
• Public title: A phase I dose escalation study of Apatinib in combination with concurrent chemoradiation for patients with locally advanced squamous cell carcinoma of esophagus
• Scientific title: A phase I dose escalation study of Apatinib in combination with concurrent chemoradiation for patients with locally advanced squamous cell carcinoma of esophagus
• Date of first enrolment: 2016-03-01
• Target sample size: the first cohort:3;the second cohort:3;the third cohort:3;the fourth cohort:3;Intervention Group(1-4):22;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=13237
• Study type: Observational study
• Study design: Non randomized control
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Jin Gang
• Affiliation: Secondly Hospital, Shanxi Medical University

• Name: Jin Gang

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old;
2. Histologically proven esophageal squamous cell carcinoma;
3. Patients are reluctant to surgery or can not tolerate surgery or the patient's stage are III-IVa;
4. KPS>=70, Life expectancy >=6 months;
5. Major organ function has to meet the following criteria: HB >=100g/L,ANC >=1.5*10^9/L, PLT >=100*10^9/L, Bilirubin <1.5 times the upper limit of normal (ULN), ALT and AST <1.5*ULN, Cr<=1.5*ULN;
6. No prior treatments of irradiation;
7. No prior treatments of chemotherpy within 6 months;
8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Exclusion criteria: 1. Confirmed that apatinib and/or its accessories and 5-flouracial and cis-platinum allergy;
2. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man >450 ms, for woman >470 ms) together with Class II cardiac dysfunction;
3. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
4. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
5. Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed;
6. Associated with CNS (central nervous system) metastases;
7. Pregnant or lactating women;
8. Pts with other malignant tumor within 5 years (except cured skin basal cell carcinoma and cervical carcinoma);
9. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
10. Participated in other clinical trials within 4 weeks;
11. Pts received VEGFR inhibitor treatment (i.e. sorafenib, sunitinib);
12. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
13. Other conditions regimented at investigators' discretion.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Esophageal Cancer

Intervention(s)

the first cohort:Apatinib Mesylate Tablets 250 mg qd p.o.;the second cohort:Apatinib Mesylate Tablets 500 mg qd p.o.;the third cohort:Apatinib Mesylate Tablets 750 mg qd p.o.;the fourth cohort:Apatinib Mesylate Tablets 850 mg qd p.o.;Intervention Group(1-4):concurrent chemoradiation;

Primary Outcome(s)

Dose limiting toxicity;Maximum tolerance dose;

Secondary Outcome(s)

Objective response rate;Progression-free survival;Overall survival;

Source(s) of Monetary Support

self-raise