A Retrospective Clinical Study of Apatinib in Combination With Radiotherapy / Chemotherapy Second-line and Above in the Treatment of Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma

NCT03424291 | Unknown Phase 2

• 1 other identifier: AHEAD-HNP016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm the safety and efficacy of Apatinib in Combination With Radiotherapy / Chemotherapy for Second-line and Above Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause

  up to 2 year

Secondary Outcomes (4)

• Overall survival(OS)

  up to 2 year

• Objective Response Rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Duration of response（DOR）

  up to 2 year

Study Arms (1)

Apatinib plus chemoradiation

EXPERIMENTAL

Apatinib 500 mg qd po Taxus + platinum or 5FU + platinum (drug dose reference to clinical) palliative radiotherapy dose ≥ 40Gy and radical radiotherapy dose (60-70Gy)

Drug: Apatinib plus chemoradiation

Interventions

Apatinib plus chemoradiation DRUG

Apatinib 500 mg qd po Taxus + platinum or 5FU + platinum (drug dose reference to clinical) palliative radiotherapy dose ≥ 40Gy and radical radiotherapy dose (60-70Gy)

Apatinib plus chemoradiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 70 years of age.
• Pathologically confirmed advanced head and neck squamous cell carcinoma, with measurable lesions (tumor lesions CT scan diameter ≥ 10mm, lymph node lesions CT scan short diameter ≥ 15mm, the scan layer thickness is not greater than 5mm, measurable after the lesion recurrence / metastasis Received radiotherapy, frozen and other local treatment).
• Patients with recurrent or metastatic head and neck squamous cell carcinoma who have undergone radiotherapy and chemotherapy to treat disease progression.
• Note: adjuvant therapy within 6 months of recurrence, adjuvant therapy is defined as first-line treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
• Life expectancy of more than 6 months.
• Subjects underwent additional treatment of the damage recovered (NCI-CTCAE Version 4.0 Grading ≤ 1), where the interval between receiving nitrosourea or mitomycin was\> 6 weeks; receiving other cytotoxic drugs, bevacizumab (Avastin), radiotherapy or surgery ≥ 4 weeks; EGFR TKI class of targeted drugs ≥ 2 weeks.
• Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 80×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST
• ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Cr clearance ≥ 45 mL/min.
• Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and would be prepared to use the appropriate method of contraception 8 weeks after the test and the last administration of the test drug. For males, consent is to be given to contraception or surgical sterilization 8 weeks after the test and the last administration of the test drug.
• Signed the informed consent form prior to patient entry.

You may not qualify if:

• Non-squamous cell carcinoma (including squamous cell carcinoma mixed with other pathological types), nasopharyngeal carcinoma.
• Active brain metastases, meningococcal meningitis, patients with spinal cord compression, or imaging at CT or MRI examination revealed brain or pia mater disease（Patients who have completed treatment and whose symptoms are stable in the first 21 days of randomization may be enrolled in the study but may be diagnosed as having no intracerebral hemorrhage by MRI, CT or venography）.
• Uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP
• ≥90 mmHg, despite optimal medical therapy).
• grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA standards, Ⅲ \~ Ⅳ grade cardiac insufficiency, or cardiac ultrasound examination prompted left ventricular ejection Score (LVEF) \<50%.
• Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
• Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above.
• Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like.
• Long-term, unhealed wounds or fractures.
• Patients who have history of psychotropic substance abuse who can not be abstinent or who have mental disorders.
• According to the researchers' judgment, there are other serious patients who are endangered or have concomitant diseases that affect the completion of the study.
• Patients with CNS metastases.
• Pregnant or lactating women.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

apatinib; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• hui Wu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• wei Du

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hui Wu

CONTACT

13503716710; wuhui7008@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: July 5, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: February 6, 2018

Record last verified: 2017-07

Locations

CN (1)