Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas

Endostar Combined With IP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study

The aim of this study is to explore whether endostar combined with IP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Endostar; Drug: Irinotecan; Drug: DDP

Detailed Description

This study is to explore whether endostar combined with IP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: chang jian hua, PD; Phone Number: 18017312689; Email: changjianhua@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer hospital Fudan University
      • Contact: Chang jian hua, PD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Histologically proven primary thoracic esophageal squamous cell carcinoma According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer The subject has PD after first-line chemotherapy or radiation within a year Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1 Can eat more than liquid diet; No signs before esophageal perforation 18~75 years PS:0-1 Life expectancy of ≥ 3 months ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL Ccr≤ UNL,Scr≥60 mL/min Normal electrocardiogram (ecg), the body had no unheal wounds Radiotherapy before within the scope of the normal dose and not affect subsequent treatment Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions Signed written informed consent

Exclusion Criteria:

Breast-feeding or pregnant women, no effective contraception if risk of conception exists Chronic diarrhea, enteritis, intestine obstruction which are not under control Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.

A second primary tumor (except skin basal cell carcinoma) The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms With bleeding tendency Has inherited bleeding evidence of physical or blood coagulation disorder With clear chemotherapy drug allergy Other researchers believe that patients should not participate in this testing

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endostar Combined With IP; Endostar15mg/m2 Irinotecan 60mg/m2，D1，8 DDP 60mg/m2，D1	Drug: Endostar; 15mg/d，d1-d7 civ; Other Names: ENDO; Drug: Irinotecan; 60mg/m2，D1，8; Drug: DDP; 60mg/m2，D1; Other Names: Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	from the first cycle of treatment (day one) to two month after the last cycle

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: chang jian hua, PD, PI; Principal Investigator: wang hui jie, doctor, SUBI

Publications and helpful links

General Publications

• Hu Z, Sun S, Zhao X, Yu H, Wu X, Wang J, Chang J, Wang H. Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study. Oncologist. 2022 Apr 5;27(4):253-e312. doi: 10.1093/oncolo/oyab078.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Topoisomerase I Inhibitors; Cisplatin; Irinotecan; Endostar protein
• Other Study ID Numbers: ENDO-SH-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No