Clinical trial · Interventional
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
NCT05519202CI-TRIAL-00060583unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1,Oxaliplatin, Penpulimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SOX and Penpulimab
- description
- 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.
- interventionNames
- Drug: S-1,Oxaliplatin, Penpulimab
Primary outcomes (1)
- measure
- Pathological complete response(pCR)
- timeFrame
- 2 years
- description
- the proportion of patients got pathological complete response rate
Secondary outcomes (5)
- measure
- The 1-year DFS rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.