Second-Line Chemotherapy Combined With Endostatin for Recurrent/Metastatic HN Epithelial Tumors

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The prognoses of recurrent/metastatic head and neck epithelial tumors after first-line platinum-based chemotherapy is poor. The efficacy of second-line chemotherapy for those patients that cannot be re-irradiated or re-operated is limited according to NCCN guideline and other published data. This study was designed to evaluate the efficacy and safety of endostatin combined with second-line chemotherapy for patients of recurrent/metastatic head and neck epithelial tumors that cannot be re-irradiated or re-operated after fist-line platinum-based chemotherapy.

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

Details

• Lead Sponsor: Sun Yan
• Collaborators: Beijing Cancer Hospital; Peking University
• Treatments: Endostar protein; Endostatins

Criteria

Inclusion Criteria:

1. Age ≥18 years old，<70 years old.

2. KPS ≥70.

3. Histopathology confirmed head and neck epithelial tumors, ie. Squamous cell carcinoma, adenocarcinoma, mucoepidermoid carcinoma, et al.

4. Relapse or metastasize after fist-line platinum-based chemotherapy，and the lesions cannot be re-irradiated or re-operated.

5. At least one measurable lesion (RECIST 1.1 version).

6. Life expectancy ≥ 6 months.

7. Adequate bone function: WBC≥3.0x109/L, ANC≥1.5 x109/L, HB≥90g/L, PLT≥100 x109/L. AST, ALT, Creatinine, urea nitrogen<1.25 ULN, normal coagulation function parameters.

Exclusion Criteria:

1. Malignant melanoma, lymphoma, other tumors from mesenchymal tissues.

2. Second primary malignant tumors.

3. Contraindications of chemotherapy: severe infections, significant cardiovascular disease, symptomatic arrythmia, uncontrolled diabetes mellitus, et al.

4. HIV infection, untreated chronic hepatitis B infection or carriers of HBV DNA copies >500IU/ml, active hepatitis C patients.

5. Uncontrolled hypertension.

6. Hemorrhagic tendency.

7. Epileptic seizure.

8. History of progression after anti-angiogenic target treatment.

9. History of allergy to recombinant human endostatin.

10. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.

11. Receiving treatment of other clinical trials.