Prospective, open, multicentre clinical trial (phase II) of Endostar(recombinant human endostatin) on combined radiotherapy and chemotherapy for esophageal cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001187

Enrollment

Unknown

Registered

2010-12-08

Start date

2011-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

?B, III, IV esophageal cancer

Interventions

1:Endostar: 7.5mg/m2, D1-D14, D21-35

for 2 cycles

Paclitaxel Injection: 175mg/m2, D1

DDP: 75-90mg/m2, D1

E=6MV, GTV-P: 60-66Gy/30-33every time/6~7w (2Gy-2.1/every time), CTVN-P: 51Gy/30 (1.7Gy/every time)

2:Paclitaxel Injection: 175mg/m2, D1

E=6MV, GTV-P: 60-66Gy/30-33every time/6-7w (2Gy-2.1/every time), CTVN-P: 51Gy/30 (1.7Gy/every time)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Clinically diagnosed with esophagus cancer by histopathology and cytology tests; (2) Aged from 18 to 70 ages, Male/Female, estimated survival time>=12 weeks; (3) All the patients should have target lesions that are measurable and evaluable; (4) Should be able to consume liquid diet, no esophageal perforation symptoms, no distant metastases; (5) PS grade: 0-1; (6) Normal organic functions: thrombocyte> 100,000/mm3; hemoglobin> 10 g/dl; neutrophilicgranulocyte>1.5*10^3/mm3; Serum creatinine=1L & >40% of corresponding value of normal people; (7) Sign the Information consent forms.

Exclusion criteria

Exclusion criteria: (1) Allergic to taxol; (2) With other malignant tumours (except the non-melanoma skin cancer and Cervical carcinoma in situ); (3) Pregnant or breast-feeding women and women refusing birth control during therapy; (4) With apparent hepatic disease; (5) With serious pulmonary diseases or heart diseases; (6) Refuse or unable to sign the Information consent forms; (7) With drug abuse or alcohol addiction; (8) With physical or mental illness, without civil capacity or with limited civil capacity; (9) Patients with uncontrolled infections; (10) Previously administration with anti-EGFR monoclonal antibody; (11) Rreceived other drugs in clinical trials within 30 days.

Design outcomes

Primary

Measure	Time frame
the objective response rate(RR);clinical Safety;	—

Secondary

Measure	Time frame
PFS;TTP;OS;	—

Countries

China

Contacts

Public ContactJianchen LI

jianchenli6@126.com+86 591 83660063

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026