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

NCT03654612 | Unknown Phase 1

• 1 other identifier: ChinaIMF-LP02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  40 months

Secondary Outcomes (1)

• OS

  40 months

Study Arms (1)

Apatinib+S-1

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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

Also known as: S-1

Apatinib+S-1

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old, male or female;
• Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
• Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
• According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
• ECOG PS: 0-1 points;
• 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;
• The expected survival period is ≥3 months;
• 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.
• Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.

You may not qualify if:

• A person who has been confirmed to be allergic to apatinib and/or its excipients;
• 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;
• Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
• Patients who have used apatinib or tigeo in the first line
• abnormal blood coagulation (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency;
• Patients with central nervous system metastases;
• Pregnant or lactating women;
• Patients with other malignancies within 5 years;
• Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
• Patients who have participated in other drug clinical trials within 4 weeks;
• Have received VEGFR inhibitors such as sorafenib and sunitinib;
• 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;

Sponsors & Collaborators

• China International Medical Foundation: lead
• Chinese Society of Clinical Oncology: collaborator

Study Sites (1)

the Second Xiangya Hospital

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

apatinib; S 1 (combination)

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Liu Ping, doctor

CONTACT

13975157508; CYRIL0820@sina.com

Liu Bin, doctor

CONTACT

13973127325; Binglang3351@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor in oncology

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 31, 2018
• Study Start: October 16, 2018
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2021
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)