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

NCT03797625 | Completed Phase 2

• 1 other identifier: ENDO-SH-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

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

Study Arms (1)

Endostar Combined With IP

EXPERIMENTAL

Endostar15mg/m2 Irinotecan 60mg/m2，D1，8 DDP 60mg/m2，D1

Drug: Irinotecan; Drug: DDP; Drug: Endostar

Interventions

Irinotecan DRUG

60mg/m2，D1，8

Endostar Combined With IP

DDP DRUG

60mg/m2，D1

Also known as: Cisplatin

Endostar Combined With IP

Endostar DRUG

15mg/d，d1-d7 civ

Also known as: ENDO

Endostar Combined With IP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 35380726 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Irinotecan; Cisplatin; endostar protein

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• chang jian hua, PD

  PI

  PRINCIPAL INVESTIGATOR

• wang hui jie, doctor

  SUBI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: May 4, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)