Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable.
In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Camrelizumab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab; Nab-paclitaxel; S-1 | Drug | Camrelizumab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death. | 24 months |
| Peritoneal Cancer Index (PCI) assessed on preoperative CT (CT-PCI) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event (AE) rate, serious adverse event (SAE) rate, etc | According to NCI CTC Version 5.0 | 24 months |
Inclusion Criteria:
1. Age: 18 years old ≤ age ≤ 75 years old, both male and female;
2.Pathology (including histology or cytology) confirmed gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por), and HER2- (HER2 Negative: IHC 0/1+ or IHC2+ but ISH negative);
3. Confirm the diagnosis of gastric cancer peritoneal metastasis by laparoscopy, laparotomy or imaging examination;
4. According to the RECIST1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of the CT scan of the tumor lesion is ≥10mm, the short diameter of the CT scan of the lymph node lesion is ≥15mm, and the scan slice thickness is 5mm;)
5. The damage caused by the patient's other treatments has recovered, and the interval between receiving nitroso or mitomycin is ≥ 6 weeks; receiving other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
6. ECOG PS: 0-2;
7.Expected survival ≥ 12 weeks;
8. The main organs function normally and meet the following criteria:
Routine blood: (no blood transfusion within 14 days):
Blood biochemistry:
9. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; for men, surgical sterilization or Agree to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the trial drug;
10. Not participating in other clinical studies before and during treatment;
11. The patients voluntarily joined the study, signed the informed consent to participate in the experimental treatment, and agreed to participate in the observational study, with good compliance and cooperation with follow-up;
12. Has a quantifiable CT-PCI score.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Xiao, Phd | Contact | 13906036392 | xiaolibohan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Xiao, Phd | Zhongshan Hospital Affiliated to Xiamen University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 24 months |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| C079198 | S 1 (combination) |
Not provided
Not provided
Not provided