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

NCT ID: NCT03654612

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2021-09-01

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib+S-1

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

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle

Interventions

Apatinib

Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle

Intervention Type: DRUG

Other Intervention Names

S-1

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

China International Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Ping Liu

Attending doctor in oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Second Xiangya Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu Ping, doctor

Role: CONTACT

CYRIL0820@sina.com

13975157508

Liu Bin, doctor

Role: CONTACT

Binglang3351@qq.com

13973127325

Facility Contacts

ping liu

Role: primary

cyril0820@sina.com

(+86)13975157508

Other Identifiers

ChinaIMF-LP02

Identifier Type: -

Identifier Source: org_study_id