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Multicenter clinical study for Anlotinib Hydrochloride Capsule combined with Gemcitabine/ Cisplatin in the treatment of locally advanced Nasopharyngeal Carcinoma

Multicenter clinical study for Anlotinib Hydrochloride Capsule combined with Gemcitabine/ Cisplatin in the treatment of locally advanced Nasopharyngeal Carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023678
Enrollment
Unknown
Registered
2019-06-07
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Nasopharyngeal carcinoma

Interventions

1:Fasting oral Anlotinib Hydrochloride Capsules 1 capsule daily+GP induced chemotherapy+IMRT concurrent chemotherapy
2:GP induced chemotherapy+IMRT concurrent chemotherapy

Sponsors

Wuzhou Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Gender is not limited, aged 18 to 70 years; 2) Pathologically confirmed non-differentiated non-keratinized carcinoma of the nasopharynx and differentiated non-keratinized carcinoma; 3) Patients who meet the III-IVA in the UICC/AJCC 8th Edition/China 2017 edition; 4) Karsten score = 70 points; 5) There are MRI and other imaging data of the nasopharynx before treatment, and there are tumor lesions that can be measured; 6) This treatment must be the first treatment; 7) Expected survival expectation not less than 6 months; 8) Patients enrolled must also meet the following clinical laboratory criteria: hemoglobin, white blood cells, platelets, and liver and kidney function indicators are within 1.25 times the upper and lower limits of normal values. 9) Can understand the study and have signed an informed consent form; 10) There are follow-up conditions.

Exclusion criteria

Exclusion criteria: 1) Previously suffered from other malignant tumors (except for stage I non-melanoma skin cancer or cervical carcinoma in situ). 2) Those who received the current internationally recognized systemic treatment for effective anti-tumor treatments before enrollment. 3) Pregnant or lactating women, women of childbearing age are not contraceptive. 4) Those who are receiving other drug trials. 5) Those with severe comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes. 6) Those who do not have regular follow-up conditions. 7) Cannot accept MRI inspectors. 8) Those who cannot meet the prescription dosage requirements. 9) Those with a significant tendency to major bleeding.

Design outcomes

Primary

MeasureTime frame
ORR;Adverse reactions;1, 3 year survival rate;

Countries

China

Contacts

Public ContactJinhui Liang

Wuzhou Red Cross Hospital

566jv@Sina.cn+86 13878480806

Outcome results

None listed

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