Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Apatinib plus Camrelizumab combined with docetaxel and S-1 as the first-line treatment of metastatic adenocarcinoma of gastric and gastroesophageal junction.
Interventions
DRUGCamrelizumab
Camrelizumab (200mg) will be given i.v. on day 1 of each 3-week cycle
DRUGApatinib Mesylate
Apatinib (250mg) will be administered orally once a day .
DRUGS1
S1 (BSA\<1.25 40mg, BSA \>=1.25-\<1.5 50mg, BSA \>=1.5 60mg) will be administered orally twice daily on days 1-7 of each 3-week cycle
DRUGDocetaxel injection
Docetaxel (75mg/m2 IV.drop) will be administered on day 1 of each 3-week cycle, for six cycles.
Sponsors
Hubei Cancer Hospital
Henan Provincial People's Hospital
Huangshi Central Hospital
Zhou Fuxiang
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
1. Aged between 18 and 75 years; 2. Has histologically or cytologically diagnosed with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) including gastroesophageal junction adenocarcinoma; 3. Human epidermal growth factor receptor 2 (HER2) negative: immunohistochemical (IHC) - or +; IHC ++ and fluorescence in situ hybridization (FISH) -; 4. No previous systemic therapy (chemotherapy, targeted therapy, immunotherapy, biological therapy, etc.) for GC/GEJ. Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. Anti-tumor traditional Chinese medicine is forbidden within 2 weeks before the first cycle chemotherapy. Patients are allowed to receive palliative radiotherapy (primary tumor or metastasis), but lesions in radiation field cannot be defined as target lesions for assessing objective response, and radiotherapy-related adverse reactions must be restored to at least grade 1； 5. Expected survival time ≥ 3 months; 6. Eastern Cooperative Group (ECOG) performance status score 0 or 1; 7. Weight ≥40kg, or BMI\>18; 8. 1 measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1; 9. All acute toxic events (excluding hair loss, fatigue and hearing loss) caused by previous anti-tumor treatments or surgery are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified by the inclusion/
Exclusion criteria
of this study； 10. The main organ function of cases should be normal, and meet the following criteria: ① Absolute neutrophil count (ANC)≥1.5×109/L, platelet (PLT) ≥80×109/L; ② Total bilirubin (TBIL) \<1.5 upper limit of normal (ULN), ALT (glutamic-pyruvic transaminase）and AST(glutamic-oxalacetic transaminase)≤2.5ULN. For subjects with liver metastases, ALT and AST≤5 ULN, serum Cr≤1.5ULN or endogenous creatinine clearance \>50ml /min (Cockcroft-Gault formula); ③ International normalized ratio (INR) \<1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN; ④ Urine protein\<2+; if urine protein≥2+, the 24-hour urine protein quantitative detection value must be ≤1g; 11. Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and willing to use appropriate contraception during the study period until at least 3 months after the last administration of the test drugs. Non-sterilized males who are sexually active must agree to use adequate contraception during the study period a until at least 3 months after the last administration of the test drugs; 12. Fully understand the study and voluntarily sign the informed consent form (ICF); willing and able to comply with planned visits, treatments, laboratory examinations and other procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 36 months | PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 36 months | Defined as percentage of participants achievingassessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1. |
| overall survival (OS) | 36 months | OS is the time from enrollment to death due to any cause. |
| disease control rate (DCR) | 36 months | DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator |
| adverse events (AE) | 36 months | overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use. |
Countries
China
Contacts
Primary ContactFuxiang Zhou, M.D.
Backup ContactHuangang Jiang, M.D.
Outcome results
None listed