Advanced Gastric Cancer
Conditions
Keywords
Apatinib Albumin-paclitaxel Camrelizumab Gastric cancer
Brief summary
This study is to evaluate the tolerance of albumin paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination.
Detailed description
This is a Single arm, open, phase I / II clinical trial. The study was divided into tolerance observation stage (dose exploration stage) and efficacy expansion stage (dose expansion stage). This study is to evaluate the tolerance of albumin-paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination. The secondary objective was to evaluate the safety and efficacy of albumin- paclitaxel in combination with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer.
Interventions
DRUGAlbumin-paclitaxel, Apatinib, Camrelizumab
Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8, Repeat the therapeutic schedule every 3 weeks; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day, Q3W;
Sponsors
China Medical University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ). 2. Age: 18-70 years old, Female or Male. 3. Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on platinum and / or fluorouracil drugs. 4. ECOG performance status 0-1. 5. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. If the progress is confirmed and meets the RECIST 1.1 standard, it can also be used as target lesion. 6. An expected survival of \> 12 weeks. 7. Be able to swallow tablets normally. 8. All acute toxic reactions caused by previous anti-tumor treatment or surgery were relieved to level 0-1 (according to NCI CTCAE version 4.03) or to the level specified in the inclusion /
Exclusion criteria
. Except for other toxicity that researchers think does not pose a safety risk to patients, such as hair loss. 9. Has adequate sufficient organ and bone marrow functions. 10. Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug and must agree to use a medically approved effective contraceptive during the study period and within 90 days of the last dose of the study drug; Male subjects whose partners are women of child-bearing age should undergo surgical sterilization or agree to use effective methods of contraception during the study period and within 90 days of the last study administration. 11. Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity [DLT] | Each 21 days up to Dose-Limiting Toxicity (12-13 months) | Dose-Limiting Toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate [ORR] | Up to 13-16 months | Objective Response Rate |
| Duration of response [DoR] | Up to 13-16 months | Duration of response |
| Time To Response [TTR] | Up to 13-16 months | Time To Response |
| Incidence and degree of Adverse Events and Serious Adverse Events [Safety] | Until 30 day safety follow-up visit (Up to 14-18 months) | Incidence and degree of Adverse Events and Serious Adverse Events |
| Progression Free Survival [PFS] | Up to 13-16 months | Progression Free Survival |
| Overall Survival [OS] | Up to 14-18 months | Overall Survival |
| Disease Control Rate [DCR] | Up to13-16 months | Disease Control Rate |
Countries
China
Contacts
Primary ContactYunPeng Liu, PhD
Backup ContactXiujuan Qu, PhD
Outcome results
None listed