Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study

NCT05441254 | Unknown Phase 2

• 1 other identifier: 2022-0627
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stage IV Gastric Cancer With Metastasis

Keywords

Camrelizumab; Nab-paclitaxel; Peritoneal Metastasis; Intraperitoneal Infusion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Overall survival (OS)

  24 months

• Peritoneal Cancer Index (PCI) assessed on preoperative CT (CT-PCI)

  24 months

Other Outcomes (1)

• Adverse event (AE) rate, serious adverse event (SAE) rate, etc

  24 months

Study Arms (1)

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;

Drug: Camrelizumab; Nab-paclitaxel; S-1

Interventions

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.

Also known as: Arm PD-1

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 years old ≤ age ≤ 75 years old, both male and female;
• 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);
• \. Confirm the diagnosis of gastric cancer peritoneal metastasis by laparoscopy, laparotomy or imaging examination;
• \. 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;)
• \. 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;
• \. ECOG PS: 0-2;
• Expected survival ≥ 12 weeks;
• \. The main organs function normally and meet the following criteria:
• Routine blood: (no blood transfusion within 14 days):
• HB≥100g/L,
• WBC≥3×109/L,
• ANC≥1.5×109/L,
• PLT≥100×109/L;
• Blood biochemistry:
• BIL \<1.5ULN,

You may not qualify if:

• \. Patients who have previously received treatment with albumin-paclitaxel, Sigio, and camrelizumab; or patients who have previously received other immunotherapy (including other clinical research drugs) within 5 half-lives from the first study drug;
• \. Concomitant Difficulties in swallowing, complete or incomplete gastrointestinal obstruction, active bleeding in the gastrointestinal tract, perforation, etc., etc.;
• \. Participating in other clinical studies within 1 month before enrollment and the toxicity has not recovered;
• \. There are a large number of Patients with ascites requiring frequent drainage that interferes with normal treatment;
• \. Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism , including but not limited to these diseases or syndromes); patients requiring no intervention in adulthood, except for vitiligo or cured childhood asthma/allergies; autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones ; Type I diabetes mellitus using stable doses of insulin;
• \. A history of immunodeficiency, including HIV test positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
• \. Accompanied by severe heart, lung, liver and kidney diseases; neurological and mental diseases; jaundice or gastrointestinal obstruction and concomitant severe infection;
• \. pregnant or breastfeeding women;
• \. The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which can manifest as clinical symptoms, cerebral edema, spinal cord compression meningitis, leptomeningeal disease, and/or progressive growth. CNS metastases are adequately treated, and neurological symptoms can return to baseline levels at least 2 weeks before enrollment (residual signs or symptoms associated with CNS treatment can be enrolled in the study). In addition, patients must discontinue corticosteroids or receive ≤10 mg/d of stable or tapered doses of prednisone (or equivalent doses of other corticosteroids) at least 2 weeks prior to enrollment;
• \. Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation \> 450 ms in men, \> 470 ms in women) and cardiac insufficiency;
• \. Patients with clear gastrointestinal bleeding tendency, including the following conditions: Patients with locally active ulcer lesions, fecal occult blood (++), and a history of melena and hematemesis within 2 months; patients with abnormal coagulation function (INR\>1.5, APTT\>1.5 ULN);
• \. The patient has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) ) Clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after clinical intervention;
• \. History of interstitial lung disease (except radiation pneumonitis without hormone therapy), non-infectious pneumonia medical history;
• \. Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour urine protein quantification \>1.0g);
• \. Those who are allergic to the experimental drug or its excipients;

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; S 1 (combination)

Study Officials

• Li Xiao, Phd

  Zhongshan Hospital Affiliated to Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xiao, Phd

CONTACT

13906036392; xiaolibohan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 8, 2022

Record last verified: 2022-07