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Recombinant human endostatin (Endostar) continuous pump infusion combined with concurrent radiochemotherapy in patients with esophageal squamous cell cancer: a prospective, randomized controlled clinical study

Recombinant human endostatin (Endostar) continuous pump infusion combined with concurrent radiochemotherapy in patients with esophageal squamous cell cancer: a prospective, randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009926
Enrollment
Unknown
Registered
2016-11-19
Start date
2016-12-01
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

Esophageal cancer

Interventions

1:Endostar:15mg/d, continuous pump infusion within 1 week before radiotherapy, and then concurrent with radiothetapy (continuous pump infusion for 5 days, and then rest for 2 days), total 6 weeks. Rad
Involved field irradiation(IFI), GTV for esophageal primary tumor, GTVnd for metastatic lymph nodes,&
2: Radiotherapy: 3D-CRT/IMRT/IGRT
Involved field irradiation(IFI), GTV for esophageal primary tumor, GTVnd for metastatic lymph nodes, CTV as 3cm upward and 4cm downward of GTV
95% prescription dose: PGTV 60-66Gy/30-33f, PTV 46-50Gy/23-25f.Chemotherapy: Docetaxel 60mg/m2, d1
Cisplatin 25mg/m2,d1-3
21-28d/cycle, 2-4cycles.

Sponsors

Gansu Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Voluntary participation and sign informed consent; (2) Aged from 18 to 75 years old, Male/Female; (3) The disease was diagnosed as esophageal squamous cell carcinoma with histopathology and cytology; (4) Clinical stage II / III; (5) Initial treatment (previously be not received chemotherapy, radiotherapy, molecular targeted drug and other anti-tumor treatment); (6) Primary tumors can be measured; (7) No distant metastasis; (8) PS grade 0-1; (9) Expected survival =3 months; (10) Female during the reproductive period should be ensured contraception during the study period; (11) Normal organic functions: Hemoglobin?100g/L, WBC?4*10^9/L, platelet ? 100*10^9/L; Serum creatinine50% of corresponding value of normal people; (12) The patient has good adherence to treatment and follow-up.

Exclusion criteria

Exclusion criteria: (1) Distant metastasis; (2) Primary tumor or metastatic lymph node have be treated with surgery (except biopsy, radiotherapy, chemotherapy and molecular targeted therapy; (3) Diagnosed with other malignancies in latest 5 years (excluding cured cervical cancer in situ / skin baseCell carcinoma / bladder epithelial tumor); (4) Received other medicine trials in past 1 month; (5) Pregnant or lactating women and women who reject contraception during the study period; (6) People with a history of severe allergies or specific physical conditions; (7) History of severe pulmonary or heart disease; (8) Refusing or failing to sign informed consent; (9) Abuse of drugs or alcohol addicts; (10) Persons with mental illness, who are incapable of civil conduct or have limited civil capacity.

Design outcomes

Primary

MeasureTime frame
Objective Respond Rate;Progression-free Survival, PFS;

Secondary

MeasureTime frame
Overall Survival, OS;

Countries

China

Contacts

Public ContactWei Shihong

The Cancer Hospital of Gansu Province

weishihong100@163.com+86 13919252973

Outcome results

None listed

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