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Trial Title:
Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer
NCT ID:
NCT05519202
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Conditions: Keywords:
Gastric Cancer, SOX, PD-1, perioperative period
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S-1,Oxaliplatin, Penpulimab
Description:
S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2
(d1)
Arm group label:
SOX and Penpulimab
Other name:
SOX and Penpulimab
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 31, 2022
Completion date:
August 31, 2024
Lead sponsor:
Agency:
The Central Hospital of Lishui City
Agency class:
Other
Source:
The Central Hospital of Lishui City
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519202
