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Short-term efficacy fety of high dose nimotuzumab in combination with concurrent chemoradiationas first-line treatment for patientswith local advanced esophageal squamous cell carcinoma : A Multicenter Study.

Short-term efficacy fety of high dose nimotuzumab in combination with concurrent chemoradiationas first-line treatment for patientswith local advanced esophageal squamous cell carcinoma : A Multicenter Study.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007059
Enrollment
Unknown
Registered
2015-09-14
Start date
2015-10-01
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 carcinoma

Interventions

treatment:radiotherapy
treatment:Chemotherapy
treatment:nimotuzumab

Sponsors

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Volunteered to participate signed a written informed consent; Aged 18~70 years old; Both male female; Esophageal squamous cell carcinoma (ESCC) confirmed by histology, unresectable advanced ESCC patients,never received chemotherapy; Have at least one measurable lesion that can be measured (base on RECIST 1.1 )Imaging diagnosis within 15 days before day 0; Expected lifetime>=3month; ECOG performance is 0~1; Hematological examination (=1g/L; WBC>=4.0*10^9/L, NEUT>=2.0*10^9/L, PLT>=100.0*10^9/L, TBil38 degree C; Normalelectrocardiogram/cardiac function; According the protocolto follow-up for observation of efficacy fety; Treatment compliance; Without bad hobby such as drug abuser; Effective contraceptive measures should be taken during crop growth period.

Exclusion criteria

Exclusion criteria: Previously received chemotherapy; Allergyic to drugs in the protocol; Multiple metastatic organs such as liver lung; Complicated with other malignant cancers except cured skin bal cell carcinoma cervical carcinoma in situ; Complicated with other important viscera disease including serious heart disease; Complicated with chronic diarrhea renal insufficiency; Neurological or psychological disorders affecting cognitive abilities, including CNS metastasis; Pregnant or lactating women(pre-menopaul women should check urine pregnancy experiment before entry).

Design outcomes

Primary

MeasureTime frame
ORR;fety;

Secondary

MeasureTime frame
Time to Progression;Progression free survival;overall survival;

Countries

China

Contacts

Public ContactSUN XIAONAN
sunxiaonan@hotmail.com+86 13606618387

Outcome results

None listed

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