Advanced Cancer, Apatinib, Mucosal Melanoma, SHR-1210
Conditions
Brief summary
There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
Detailed description
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma
Interventions
DRUGapatinib plus SHR-1210
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* mucosal melanoma by pathology * expected lifespan ≥ 3 months * ECOG 0-2 * failure after one kind of chemotherapeutic regimen * at least one measurable lesion by RECIST 1.1 * enough organ function * blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs * no other serious diseases conflicting with this regimen * no history of other malignancies * pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study * informed consent from the patient
Exclusion criteria
* Suffering from serious infectious diseases within 4 weeks before enrollment * requiring intermittent use of bronchodilators or medical interventions * usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks * serious allergy * serious mental diseases * abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy * abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment * previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc. * other situations evaluated by investigator unsuitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | three months | the proportion of patients with CR, PR, and SD in the group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | six months | the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first. |
| overall survival | eighteen months | the time frame from the first day of apatinib to the date of death |
Countries
China
Contacts
Primary ContactLingdi Zhao, Dr.
Backup ContactYonghao Yang, Master
Outcome results
None listed