Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer

A Single-arm, Single-center Exploratory Clinical Study of Penpulimab Injection Combined With SOX in the Perioperative Treatment of Gastric Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: S-1,Oxaliplatin, Penpulimab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xu Hong Tao, MS; Phone Number: 15024622762; Email: xht0071@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SOX and Penpulimab; S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1) The treatment period of the above drugs was 3 weeks, and the duration of preoperative treatment was 3 cycles. After treatment, the patient underwent surgery after evaluation. Four cycles of adjuvant therapy with the original regimen (preoperative) were performed after surgery.

Drug: S-1,Oxaliplatin, Penpulimab; S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1); Other Names: SOX and Penpulimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response(pCR)	the proportion of patients got pathological complete response rate	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 1-year DFS rate	the proportion of patients without relapse	1 years
The 1-year OS rate	OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up	1 years
Disease free survival,DFS	defined as, according to the RECIST1.1 criteria, the time between subjects from enrollment to disease recurrence or death (for any reason)	2 years
Overall Response Rate (ORR)	ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1	2 years
tumor regression grade(TRG)	Ryan's 0-3 classification method was used	2 years

Collaborators and Investigators

• Sponsor: The Central Hospital of Lishui City

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Gastric Cancer, SOX, PD-1, perioperative period
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: ZJLS-KLDMIR-22209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No