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To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate, nab-paclitaxel and S-1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab + Apatinib + nab-paclitaxel +S-1 | Experimental | Camrelizumab combined with Apatinib mesylate tablets, nab-paclitaxel and S-1 in the treatment of locally advanced gastric cancer |
|
| nab-paclitaxel +S-1 | Active Comparator | nab-paclitaxel and S-1 in the treatment of locally advanced gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab One course will last 21 days.Given once every 3 weeks at a dose of 200 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| major pathological response | major pathological response(MPR) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response | pathological complete response (pCR) | 4 months |
| Objective response rate | Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST |
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Inclusion Criteria:
Age: 18-75 years of age
Gastric adenocarcinoma was confirmed by pathology( including histology or cytology)。
CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.
measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.(CT scan of tumor lesion length≥10mm,CT scan short diameter≥15mm,scan slice thicknes 5mm)
ECOG(Eastern Cooperative Oncology Group)PS(Performance Status):0-1 scores;
the expected survival time is more than 12 weeks
the main organ function is normal, which should meet the following criteria:
(1) blood routine examination standards should be met(no blood transfusion within 14 days)
a.HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L (2)biochemical examination shall comply with the following criteria:
women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test。
No other clinical studies were conducted before and during the treatment
participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38167806 | Derived | Lin JX, Tang YH, Zheng HL, Ye K, Cai JC, Cai LS, Lin W, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Zheng CH, Li P, Huang CM. Neoadjuvant camrelizumab and apatinib combined with chemotherapy versus chemotherapy alone for locally advanced gastric cancer: a multicenter randomized phase 2 trial. Nat Commun. 2024 Jan 2;15(1):41. doi: 10.1038/s41467-023-44309-5. |
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| Apatinib Mesylate | Drug | Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday。 |
|
| nab-paclitaxel | Drug | nab-paclitaxel One course will last 21 days。Given twice every 3 weeks at a dose of 125 mg/m2. |
|
| S1 | Drug | S-1 was calculated according to body surface area , P.O., bid, d1-d14。And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time |
|
| 4 months |
| R0 resection rate | The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy. | 4 months |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| C520255 | 130-nm albumin-bound paclitaxel |
| C079198 | S 1 (combination) |
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