Clinical trial NCT05519202: Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer
Official title: A Single-arm, Single-center Exploratory Clinical Study of Penpulimab Injection Combined With SOX in the Perioperative Treatment of Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric Cancer, SOX, PD-1, perioperative period
Lead sponsor: The Central Hospital of Lishui City
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer

Detailed description: Gastric cancer is one of the malignant tumors that seriously threaten human health. It is the sixth most common malignant tumor in the world. According to Global Cancer Statistics 2020, there were about 1.089 million new cases of gastric cancer and 768,000 deaths of gastric cancer worldwide in 2020. Multidisciplinary treatment with radical surgical resection as the core is the mainstream mode of comprehensive treatment of gastric cancer at present, and radical gastrectomy is recognized as the best treatment. However, for patients with advanced gastric cancer, the effect of surgery alone is not good, and the postoperative tumor recurrence rate is high. In order to improve the disease-free survival rate and overall Surv Ival (OS) rate of gastric cancer patients after surgery, perioperative comprehensive therapy has been gradually adopted by the majority of scholars, and has achieved encouraging efficacy in clinical application.

Eligibility criteria: Inclusion Criteria:

* signed and dated informed consent;
* At least 18 years of age;
* ECOG PS: 0-1;
* Patients with gastric cancer diagnosed as T3-4NXMX by imaging;
* Patients with gastric adenocarcinoma diagnosed by cytology;
* Patients with gastric cancer assessed by the surgeon as suitable for neoadjuvant therapy or conversion therapy followed by radical resection;
* Laboratory tests should meet the following requirements (28 days before enrollment in baseline period) :
* Women should agree that they must use contraception during and for 6 months after the study; Had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating; Men should agree that they must use contraception during the study and for 6 months after the end of the study period.

Exclusion Criteria:

* Co-existing with other malignant tumors (except cured basal cell carcinoma of the skin);
* Gastric cancer patients with T1-2N0M0;
* Previous treatment including anti-PD-1 /PD-L1/CTLA-4 antibody therapy or other immunotherapy directed against PD-1/PD-L1/CTLA-4;
* Weight loss greater than or equal to 20% within 4 weeks before the first dose;
* Severe hypersensitivity after administration of other monoclonal antibodies;
* The presence or history of any active autoimmune disease
* Immunosuppressive therapy, systemic or absorbable local hormone therapy (dose \> 10mg/ day prednisone or other effective hormone) is required to achieve immunosuppression and continues to be used within 2 weeks of the first administration;
* Patients with multiple factors affecting oral medication
* Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
* Had received a prophylactic or attenuated vaccine within 4 weeks before the first dose;

Primary outcomes:
measure: Pathological complete response(pCR)
timeFrame: 2 years
Secondary outcomes:
measure: The 1-year DFS rate
timeFrame: 1 years
measure: The 1-year OS rate
timeFrame: 1 years
measure: Disease free survival,DFS
timeFrame: 2 years
measure: Overall Response Rate (ORR)
timeFrame: 2 years
measure: tumor regression grade(TRG)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: