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Status unknownNCT03424291Updated Feb 6, 2018

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

A Phase 2 interventional study of Apatinib plus chemoradiation in Head and Neck Squamous Cell Carcinoma, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Head and neck cancer refers to the skull base to the supraclavicular, cervical spine within the scope of all malignant tumors is more common in China's malignant tumors. Head and neck cancer mainly surgery and radiotherapy, chemotherapy alone or in combination therapy, common head and neck squamous cell carcinoma chemotherapy programs are: PF regimen (cisplatin + 5-fluorouracil), PLF program (cisplatin + carboplatin +5 - fluorouracil), TPF program (cisplatin + 5 - fluorouracil + paclitaxel) and so on. The researcher consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥ 18 and ≤ 70 years of age.
  2. 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).
  3. 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.

  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
  5. Life expectancy of more than 6 months.
  6. 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.
  7. 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.

  8. 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.
  9. Signed the informed consent form prior to patient entry.

Exclusion criteria

Exclusion Criteria:

  1. Non-squamous cell carcinoma (including squamous cell carcinoma mixed with other pathological types), nasopharyngeal carcinoma.
  2. 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).
  3. Uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP

    ≥90 mmHg, despite optimal medical therapy).

  4. 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%.
  5. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
  6. 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.
  7. 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.
  8. Long-term, unhealed wounds or fractures.
  9. Patients who have history of psychotropic substance abuse who can not be abstinent or who have mental disorders.
  10. According to the researchers' judgment, there are other serious patients who are endangered or have concomitant diseases that affect the completion of the study.
  11. Patients with CNS metastases.
  12. Pregnant or lactating women.
  13. Researchers think it is not suitable for inclusion.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Apatinib plus chemoradiation

    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

  • DrugApatinib plus chemoradiation

    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)

05

What researchers measure

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

    Time frame: up to 2 year

Secondary outcomes

  1. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Time frame: up to 2 year

  2. Objective Response Rate (ORR)

    From date of randomization until the date of death from any cause

    Time frame: up to 1 year

  3. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD)

    Time frame: up to 1 year

  4. Duration of response(DOR)

    Time frame: up to 2 year

06

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03424291
Lead sponsor
Henan Cancer Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 6, 2018
Start date
Jul 5, 2017
Primary completion
Jul 2018 (estimated)
Completion
Jul 2019 (estimated)
Last update
Feb 6, 2018

Study contacts

hui Wu
Contact
wuhui7008@126.com
13503716710
hui Wu
principal investigator · Henan Cancer Hospital
wei Du
principal investigator · Henan Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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