Gastric CancerPhase 2NCT05519202
Exploratory Clinical Study of Penpulimab Combined With SOX in the Perioperative Treatment of Gastric Cancer
A Phase 2 study testing S-1,Oxaliplatin, Penpulimab in people with Gastric Cancer, run by The Central Hospital of Lishui City.
Trial summary
To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1,Oxaliplatin, Penpulimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2022to 31 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
- Conditions
- Gastric Cancer
- Being tested
- S-1,Oxaliplatin, Penpulimab
- Keywords
- Gastric Cancer, SOX, PD-1, perioperative period
- Medical subject headings
- Stomach Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1,Oxaliplatin, PenpulimabDrug
Also called SOX and Penpulimab
S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: S-1,Oxaliplatin, Penpulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response(pCR)
the proportion of patients got pathological complete response rate
Measured: 2 years
Secondary outcomes (5)
The 1-year DFS rate
the proportion of patients without relapse
Measured: 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
Measured: 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)
Measured: 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
Measured: 2 years
tumor regression grade(TRG)
Ryan's 0-3 classification method was used
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start31 Aug 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519202
- Sponsor's protocol ID
- ZJLS-KLDMIR-22209
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Exploratory Clinical Study of Penpulimab Injection Combined With SOX in the Perioperative Treatment of Gastric Cancer
- ClinicalTrials.gov ID
- NCT05519202
- Acronym / sponsor ID
- ZJLS-KLDMIR-22209
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, SOX, PD-1, perioperative period
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Study start
- 31 Aug 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX and Penpulimab | Experimental | Drug: S-1,Oxaliplatin, PenpulimabS-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1,Oxaliplatin, PenpulimabAlso: SOX and PenpulimabS-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1) | Drug | SOX and Penpulimab |
Primary outcome
Pathological complete response(pCR)
Time frame: 2 years
the proportion of patients got pathological complete response rate
5 secondary outcomes
The 1-year DFS rate
Time frame: 1 years
The 1-year OS rate
Time frame: 1 years
Disease free survival,DFS
Time frame: 2 years
Overall Response Rate (ORR)
Time frame: 2 years
tumor regression grade(TRG)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1,Oxaliplatin, Penpulimab in people with Gastric Cancer, run by The Central Hospital of Lishui City.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Hong Tao, MS (15024622762, xht0071@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response(pCR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.