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

Phase 2

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: second-line chemotherapy; Drug: Recombinant human endostatin

• Registration Number: NCT03989830
• Lead Sponsor: Sun Yan

Brief 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.

Detailed Description

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. New agent for second-line treatment of recurrent and/or metastatic head and neck tumors is urgently needed. Recombinant human endostatin is an anti-angiogenetic target drug, which has been demonstrated a good efficacy for NSCLC. Studies about recombinant human endostatin in head and neck cancer mainly focus on NPC. And phase I study of endostatin combined with chemotherapy and/or radiotherapy for NPC showed a promising results.

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.

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Study Start: 2019-07-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Second-line chemotherapy combined with Endostar	second-line chemotherapy	Second-line chemotherapy+Endostar
Second-line chemotherapy combined with Endostar	Recombinant human endostatin	Second-line chemotherapy+Endostar

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months	include complete remission, partial remission, and stable disease

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	From the date of first drug administration, evaluation of response was performed every cycle during the treatment and then every 3 months after the completion of the treatment up to 36 months	include complete remission and partial remission
Progress Free Survival (PFS)	From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	1，2 years PFS
Overall Survival (OS)	From the date of first drug administration until the date of death, assessed up to 36 months	1，2 years OS

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China