Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies

Phase 1

• Conditions: Head and Neck Cancer
• Interventions: Drug: Apatinib

• Registration Number: NCT03654612
• Lead Sponsor: China International Medical Foundation

Brief Summary

This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Status Verified: 2018-10
• Study Start: 2018-10-16
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18
• Primary Completion: 2020-03-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age ≥ 18 years old, male or female;

2. Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);

3. Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;

4. According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;

5. ECOG PS: 0-1 points;

6. Baseline blood and biochemical indicators meet the following criteria:

   Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;

7. The expected survival period is ≥3 months;

8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.

9. Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.

Exclusion Criteria

1. A person who has been confirmed to be allergic to apatinib and/or its excipients;
2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male > 450 ms, female > 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
3. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
4. Patients who have used apatinib or tigeo in the first line
5. abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
6. Patients with central nervous system metastases;
7. Pregnant or lactating women;
8. Patients with other malignancies within 5 years;
9. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
10. Patients who have participated in other drug clinical trials within 4 weeks;
11. Have received VEGFR inhibitors such as sorafenib and sunitinib;
12. According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study;
13. The investigator believes that it is not suitable for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib+S-1	Apatinib	Patients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy.

Primary Outcome Measures

Name	Time	Method
PFS	40 months	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	40 months	Overall survival

Trial Locations

Locations (1)

the Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China