Gastric CancerPhase 2NCT05000554
The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
A Phase 2 study testing Neoadjuvant Therapy in people with Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Neoadjuvant Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2021to 1 Jun 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
- Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
- The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
- No bulky lymph node metastasis is detected by abdominal CT.
- No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
- No clinically apparent distant metastasis.
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- Karnofsky performance status ≥70%.
- Sufficient oral intake.
- No previous treatment with chemotherapy or radiation therapy for any tumors.
- No previous surgery for the present disease.
- Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
- No need for emergency surgery due to bleeding or perforation of the primary tumor.
- No mechanical obstruction.
- Written informed consent.
Who cannot join
- Past history of upper abdominal surgery.
- Past history of surgery for the gastrointestinal tract.
- Body mass index exceeding 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130000
Di Guo, 0431-88782013, guodi17790060921@126.com
About this study
To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
- Conditions
- Gastric Cancer
- Being tested
- Neoadjuvant Therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant TherapyProcedure or surgery
Drug:
Camrelizumab 200mg,d1，Repeat every 21 days for 3 courses； Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time，twice a day；bsa1.25~1.5m2，50mg/time，twice a day；bsa≥1.5m2,60mg/次，twice a day，d1-d14；
Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced gastric cancer | Experimental | Patients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy Receives: Procedure: Neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.
Measured: 30 days
Secondary outcomes (5)
ORR
defined as the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The sum of complete remission plus partial remission.
Measured: 30 days
PFS
Defined as the time from the start of randomization to the progression of the disease or the death of the patient.
Measured: 3 years
OS
Defined as the time between the beginning of randomization and the death of the patient for any reason.
Measured: 3 years
postoperative complication
Defined as postoperative complications that occur within 30 days of surgery, they are classified according to the Clavien-Dindo classification system.
Measured: Up to 30 days post-operative
operative mortality
Defined as death of any cause within 30 days of surgery.
Measured: Up to 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start2 Jul 2021
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (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.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000554
- Sponsor's protocol ID
- STARS-GC02
- Status last verified
- Aug 2021
- First submitted
- 28 Jun 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
- ClinicalTrials.gov ID
- NCT05000554
- Acronym / sponsor ID
- STARS-GC02
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 11 Aug 2021 (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 safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced gastric cancer | Experimental | Procedure: Neoadjuvant TherapyPatients with locally advanced gastric cancer who can receive PD-1 monoclonal antibody combined with neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
- Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
- The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
- No bulky lymph node metastasis is detected by abdominal CT.
- No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
Key exclusion criteria (3 listed)
- Past history of upper abdominal surgery.
- Past history of surgery for the gastrointestinal tract.
- Body mass index exceeding 30 kg/m2.
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 |
|---|---|---|
| Neoadjuvant TherapyDrug: Camrelizumab 200mg,d1，Repeat every 21 days for 3 courses； Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time，twice a day；bsa1.25~1.5m2，50mg/time，twice a day；bsa≥1.5m2,60mg/次，twice a day，d1-d14； Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection | Procedure or surgery | Locally advanced gastric cancer |
Primary outcome
pCR rate
Time frame: 30 days
Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.
5 secondary outcomes
ORR
Time frame: 30 days
PFS
Time frame: 3 years
OS
Time frame: 3 years
postoperative complication
Time frame: Up to 30 days post-operative
operative mortality
Time frame: Up to 30 days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Therapy in people with Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
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 14 inclusion and 3 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 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Di Guo (0431-88782013, guodi17790060921@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 30 days). 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 11 Aug 2021.