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This study is a phase II study, to evaluate the effectiveness and safety of Camrelizumab combined with apatinib for advanced gastric or esophagogastric adenocarcinoma progressed after immune checkpoint inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | camrelizumab combined with apatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab | Drug | 200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | ORR was defined as the percentage of participants with best overall response of either CR or PR | up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival(PFS) | PFS was defined as the time from the first day of treatment to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. | up to 2 years |
| Overall Survival (OS) |
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Inclusion Criteria:
The patient volunteered to participate in the study and signed an informed consent formï¼›
≥18 years old; male or female
confirmed incurable gastric and gastroesophageal junction adenocarcinoma(unresectable or metastatic) by pathological examination,at least have a measurable lesion without local treatment.(According to the RECIST V1.1,the long diameter of the lesion can be measured by spiral CT ≥10mm or the short diameter of the enlarged lymph nodes≥15mm;
Adequate standard treatment was used in the past; At least two cycles of anti-PD-1 / PD-L1 / CTLA-4 antibody therapy and platinum based chemotherapy were used in the past; Imaging confirmed disease progression occurred during or within 12 weeks after the treatment with anti-PD-1 / PD-L1 / CTLA-4 antibodyï¼›
It can provide the detection report of human epidermal growth factor receptor 2 (HER2); HER2 negative patients could be included in the study; HER2 positive patients who had failed to receive trastuzumab treatment in the past could be included in the study (HER2 positive was defined as ≥ 10% of tumor cells HER2 IHC 3 + or fish positive);
Swallowing pills normallyï¼›
ECOG score: 0~1 points;
Expected survival period ≥ 12 weeks; A histological specimen can be provided for secondary testing;
The main organ function meets the following criteria( It is not allowed to use any blood components or cell growth factor drugs within 14 days before the first medication):
The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) > 100 × 109 / L ;Albumin(ALB)≥ 90g / L;Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤3 * ULN; serum creatinine (Cr) ≤ 1.5 * ULN ; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be included in the group);Alkaline phosphatase(AKP)≤ 2.5 times the upper limit of normal (ULN).
Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the end of the study; negative serum or urine pregnancy test within 72 hours prior to study enrollment and must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 3 months after the end of the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Liu | Contact | 13783604602 | yaya7207@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Liu | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan cancer hospital/The affiliated Cancer Hospital of ZhengZhou university | Recruiting | Henan | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| Apatinib Mesylate | Drug | 250 mg qd |
|
OS was defined as the first day of treatment to death due to any cause. |
| up to 2.5 years |
| Disease control rate(DCR) | DCR was defined as the percentage of participants with best overall response of either CR or PR or SD | up to 1 years |
| Time to progression(TTP) | TTP was defined as the time from the first day of treatment to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants. | up to 2years |
| Duration of response(DOR) | DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | up to 2years |