A Phase II Clinical Trial of Chemotherapy With or Without Endostar® Continuous Intravenous Infusion in Refractory NPC

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

We define refractory nasopharyngeal carcinoma as the following: recurrence with radiation brain injury after radiotherapy, recurrence after the second or more courses of radiotherapy, standard treatment failure after recurrence, and first-line treatment failure after multiple distant metastasis.

There is no standard treatment for refractory nasopharyngeal carcinoma. Platinum plus 5-Fu is the classic regimen for primary treatment of nasopharyngeal carcinoma.

Endostatin is a multiple targeted angiogenesis inhibitor acting on tumor associated neovascular endothelial cells, normalizing the morphology and function of tumor vasculature, and indirectly leading to the quiescence or reduction of tumors.

The purpose of this phase II clinical trial is to determine the efficacy and safety of nedaplatin plus continuous low dose 5-Fu intravenous infusion combined with endostar® (Recombinant Human Endostatin Injection) continuous intravenous infusion compared with nedaplatin plus continuous low dose 5-Fu intravenous infusion alone in refractory nasopharyngeal carcinoma.

The study hypothesis is that nedaplatin plus continuous low dose 5-Fu intravenous infusion combined with endostar® continuous intravenous infusion is effective and safe in refractory nasopharyngeal carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yun-fei Xia
• Collaborator: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Endostar protein; Endostatins; Fluorouracil; Nedaplatin

Criteria

Inclusion Criteria:

• Patients have provided a signed Informed Consent Form.

• Histologically confirmed diagnosis of refractory nasopharyngeal carcinoma (the best), or when histology is difficult to obtained, the following clinical diagnosis of refractory nasopharyngeal carcinoma must be confirmed: clear and directional clinical symptoms, at least two kinds of imaging diagnosis on the basis of magnetic resonance (MR), and clear and directional signs.

• Age: 18-70 years old.

• Without dysfunction of heart, lung, liver, kidney, and hematopoiesis, and normal electrocardiogram.

• Karnofsky Performance Scores ≥ 50, Life expectancy ≥ 3 months, tolerance to at least two cycles of chemotherapy.

• At least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT or magnetic resonance (MR) scan)

• No history of serious allergic to biologic agents

• No history of other malignant tumors, except cured cervical carcinoma in situ and basal skin cancer.

Exclusion Criteria:

• Having the serious cardiovascular disease or other serious complications.

• Woman in pregnancy and breast-feeding.

• Allergic to intervention drugs and dextran.

• Patients participated in clinical trials of other drugs within 4 weeks.

• Use of other chemotherapy drugs, biological treatment, and Chinese medicine anti-cancer drugs at the same time.