A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.

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

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded.

• Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1)

• ECOG 0 or 1

• Expected survival ≥ 1 year

• Without dysfunction of heart, lung, liver, kidney and hematopoiesis

• Patients are voluntary and signed informed consent

• No other anti-tumor treatment (including steroid)

Exclusion Criteria:

• Allergy history to platinum

• Use of 5-FU in last 6 months

• Had major surgery in last 4 weeks, or the wound has not completely healed

• Toxicity from previous treatment is still ≥CTC AE grade 3

• History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin

• Dysfunction of heart

• Bleeding ≥CTC AE grade 3

• Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention

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

• Mental illness