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Status unknownNCT05519202Updated Aug 29, 2022

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

A Phase 2 interventional study of S-1,Oxaliplatin, Penpulimab in Gastric Cancer, sponsored by The Central Hospital of Lishui City. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by The Central Hospital of Lishui City · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gastric Cancer

Keywords

  • Gastric Cancer, SOX, PD-1, perioperative period
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 47 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

The Central Hospital of Lishui City is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Pathological complete response(pCR)

    the proportion of patients got pathological complete response rate

    Time frame: 2 years

Secondary outcomes

  1. The 1-year DFS rate

    the proportion of patients without relapse

    Time frame: 1 years

  2. 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

    Time frame: 1 years

  3. 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)

    Time frame: 2 years

  4. 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

    Time frame: 2 years

  5. tumor regression grade(TRG)

    Ryan's 0-3 classification method was used

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2022; primary completion for Aug 2023, 12 months later.

Of 260 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 75. This study's planned 12 months is below that.

Counting every sponsor, half of 318 studies reached it within 50 months; a quarter within 30 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2022
First posted
Aug 29, 2022
StartEst.
Aug 31, 2022
Primary completionEst.
Aug 31, 2023
CompletionEst.
Aug 31, 2024
Last update
Aug 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05519202
Lead sponsor
The Central Hospital of Lishui City
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Aug 31, 2022 (estimated)
Primary completion
Aug 31, 2023 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Aug 29, 2022

Study contacts

Xu Hong Tao, MS
Contact
xht0071@sina.com
15024622762

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Tegafur · Gimeracil · Oxonic Acid · Oxaliplatin · Penpulimab

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