Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3

Conditions: Stage IVC Nasopharyngeal Carcinoma; Effects of Chemotherapy

Treatments: Drug: Gemcitabine and cisplatin; Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01915134

ZhejaingCH-npc-03

Details and patient eligibility

About

The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Full description

To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).

Enrollment: 362 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.

Exclusion criteria

• To give local treatment,clinical severe infection(>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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362 participants in 2 patient groups

EGP group

Experimental group

Description:

the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy

Treatment:

Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin

GP group

Active Comparator group

Description:

the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy

Treatment:

Drug: Gemcitabine and cisplatin