S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study

NCT ID: NCT01854749

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30

Brief Summary

Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

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

Study Groups

S1 combined with cisplatin

Group Type: EXPERIMENTAL

S1 combined with cisplatin

Intervention Type: DRUG

Interventions

S1 combined with cisplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Joined the study voluntarily and signed informed consent form;
• Age 18-75

.Presence of at least one index lesion measurable by CT scan or MRI

• recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
• No radiotherapy, chemotherapy or other treatments prior to enrollment
• PS ECOG 0-1
• Life expectancy of more than 3 months
• ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L

• Cr≤1.0×UNL
• TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL

Exclusion Criteria

• there is radical cure of the cancer

• uncontrolled chronic diarrhea and esophageal obstruction
• Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases
• Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia
• Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix
• accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception

• 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

Deputy director of medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

S1- ESCC -CJH

Identifier Type: -

Identifier Source: org_study_id