Apatinib in the Treatment of Recurrence or Metastasis of Esophageal Cancer

NCT03913182 | Unknown Phase 2 DMC

• 1 other identifier: SCH0403
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

It was difficult to obtain clinical benefits through traditional chemotherapy and radiotherapy for the patients who have recurrence or metastasis tumor even though they have received first-line chemotherapy or combined radiotherapy before, but failed.The aim of this study was to evaluate the safety and efficacy of apatinib, an anti-angiogenesis drug, in the treatment of patients with advanced esophageal squamous cell carcinoma who had recurrence or metastasis after radical resection

Conditions

Esophageal Squamous Cell Carcinoma; Apatinib; Recurrence; Metastasis

Keywords

Esophageal squamous cell carcinoma; apatinib; recurrence; metastasis

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  2.5 months

Secondary Outcomes (3)

• OS

  through study completion, an average of 2 year

• ORR

  through study completion, an average of 2 year

• DCR

  through study completion, an average of 2 year

Study Arms (1)

apatinib group

EXPERIMENTAL

apatinib：500mg po Qd

Drug: apatinib

Interventions

apatinib DRUG

500mg po Qd

apatinib group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18;
• ECOG score 0-2;
• Postoperative pathology confirmed esophageal squamous cell carcinoma;
• Have never received targeted therapy before;
• Patients who had failed chemotherapy with platinum or paclitaxel regimens at least once in the past; Note: (1) At least one cycle of drug use, regardless of single or multiple drug combinations;(2) Neoadjuvant concurrent chemoradiotherapy, neoadjuvant chemotherapy or adjuvant chemotherapy are allowed;
• According to RECIST version 1.1, there is at least one measurable lesion;
• The estimated survival time is more than 3 months;
• The main organs are functioning well, and the examination indicators meet the following requirements:
• (1) Blood examination: Hemoglobin (\>90 g/L) (no blood transfusion within 14 days);The neutrophil count (\>1.5×109/L);Platelet count (\> 80×109/L); (2)Biochemical examination:Total bilirubin\<1.5×upper limit of normal (ULN);alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) are less than 2.5×ULN, ALT or AST are less than 5×ULN if liver metastasis occurred, and creatinine clearance is more than 50 ml/min (Cockcroft-Gault formula); 9.Sign the informed consent; 10.Good compliance, family members agreed to cooperate with survival follow-up;

You may not qualify if:

• Subjects may not enter the trial with one of the following:
• There were other malignant tumors at the same time, except cured skin basal cell carcinoma and cervical carcinoma in situ of cervix;
• Pregnant or lactating women;
• Participated in clinical trials of other drugs within one month;
• Must be able to swallow tablets;
• Any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred within 4 weeks before screening;
• Patients with central nervous system metastasis or a history of central nervous system metastasis before screening;
• Patients with hypertension who can not be well controlled by a single anti-hypertensive drug (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg); those with a history of unstable angina pectoris; those newly diagnosed as angina pectoris within the first three months of screening or those with myocardial infarction within the first six months of screening; arrhythmia require long-term use of anti-arrhythmic drugs and cardiac insufficiency \> Grade II (New York Heart Disease Association Grade) ;
• Long-term nonunion of wounds or incomplete healing of fractures;
• History of organ transplantation in the past;
• Images show that the tumors have invaded important blood vessels or tumor was highly likely to invade important blood vessels during treatment and might cause fatal massive hemorrhage;
• Patients who have bleeding tendency with abnormal blood coagulation (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L); patients treated with anticoagulant or vitamin K antagonists such as warfarin, heparin or its analogues, use a small dose of warfarin (1 mg orally once daily) or a small dose of aspirin (with a daily dose of no more than 100 mg) for prophylactic purposes under the premise of prothrombin time international normalized ratio (INR)≤1.5;
• Arteriovenous thrombosis events occurred in one year ago, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by venous catheterization due to pre-chemotherapy,but healed) and pulmonary embolism;
• Patients who have a history of psychotropic drug abuse and were unable to give up or have mental disorders;
• Patients who have a history of immunodeficiency or other acquired or congenital immunodeficiency disorders or organ transplantation;

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (2)

• Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

  PMID: 26884585 RESULT

• Dutton SJ, Ferry DR, Blazeby JM, Abbas H, Dahle-Smith A, Mansoor W, Thompson J, Harrison M, Chatterjee A, Falk S, Garcia-Alonso A, Fyfe DW, Hubner RA, Gamble T, Peachey L, Davoudianfar M, Pearson SR, Julier P, Jankowski J, Kerr R, Petty RD. Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial. Lancet Oncol. 2014 Jul;15(8):894-904. doi: 10.1016/S1470-2045(14)70024-5. Epub 2014 Jun 17.

  PMID: 24950987 RESULT

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Recurrence; Neoplasm Metastasis

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Zhigang Li

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhigang Li

CONTACT

86-021-62181990; dr_lizhigang@163.com

Xufeng Guo

CONTACT

86-021-62181990; dr_lizhigang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: no special
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of esophageal surgery

Model Details: no special

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: April 2, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (1)