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

NCT ID: NCT03797625

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-04
• Study Completion Date: 2021-12-31

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

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

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar Combined With IP

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

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

60mg/m2，D1，8

DDP

Intervention Type: DRUG

60mg/m2，D1

Endostar

Intervention Type: DRUG

15mg/d，d1-d7 civ

Interventions

Irinotecan

60mg/m2，D1，8

Intervention Type: DRUG

DDP

60mg/m2，D1

Intervention Type: DRUG

Endostar

15mg/d，d1-d7 civ

Intervention Type: DRUG

Other Intervention Names

Cisplatin; ENDO

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Chang Jian Hua

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

chang jian hua, PD

Role: PRINCIPAL_INVESTIGATOR

PI

wang hui jie, doctor

Role: PRINCIPAL_INVESTIGATOR

SUBI

Locations

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35380726 (View on PubMed)

Other Identifiers

ENDO-SH-002

Identifier Type: -

Identifier Source: org_study_id