Skip to main content
OpenTrials
Completed

NCT Number: NCT03797625

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Irinotecan

Drug

60mg/m2,D1,8

DDP

Drug

60mg/m2,D1

Other names: Cisplatin

Endostar

Drug

15mg/d,d1-d7 civ

Other names: ENDO

Primary outcomes

  1. Progression Free Survival

    Time frame: from the first cycle of treatment (day one) to two month after the last cycle

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 9, 2019
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.