NCT05519202

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_2 gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 25, 2022

Last Update Submit

August 25, 2022

Conditions

Gastric Cancer

Keywords

Gastric Cancer, SOX, PD-1, perioperative period

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response(pCR)

    the proportion of patients got pathological complete response rate

    2 years

Secondary Outcomes (5)

  • The 1-year DFS rate

    1 years

  • The 1-year OS rate

    1 years

  • Disease free survival,DFS

    2 years

  • Overall Response Rate (ORR)

    2 years

  • tumor regression grade(TRG)

    2 years

Study Arms (1)

SOX and Penpulimab

EXPERIMENTAL

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

Interventions

S-1,Oxaliplatin, PenpulimabDRUG

S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1)

Also known as: SOX and Penpulimab
SOX and Penpulimab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsParkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

penpulimab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Xu Hong Tao, MS

CONTACT

15024622762xht0071@sina.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

August 25, 2022

First Posted

August 29, 2022

Study Start

August 31, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2024

Last Updated

August 29, 2022

Record last verified: 2022-08