Gastric Cancer (GC)Phase 1NCT07923396
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
A Phase 1 study testing GK01 combination with nab-paclitaxel and S-1 in people with Gastric Cancer (GC), run by Ruijin Hospital at 1 site in China.
Trial summary
This study is a single-arm, open-label clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GK01 cell therapy in patients with gastric cancer and peritoneal metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (GC)
- What is being tested?
- GK01 combination with nab-paclitaxel and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Understands and voluntarily signs the informed consent form (ICF) before any study-related assessments/procedures are performed;
- Age ≥18 years at the time of signing the ICF;
- Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma, with no prior systemic therapy for locally advanced or metastatic gastric cancer (including targeted therapy, immunotherapy, and biologic therapy). If neoadjuvant or adjuvant therapy has been received, disease progression or recurrence must have occurred ≥6 months after the completion of neoadjuvant or adjuvant therapy.
- At least one lesion ;
- At least 1 measurable lesion (according to the RECIST 1.1 criteria);
- ECOG performance status of 0 or 1 ;
- Expected survival of more than 3 months;
- Adequate hematologic and organ reserve function;
Who cannot join
- A history of severe allergy or hypersensitivity to any component of any drug to be used in this study, including but not limited to the planned chemotherapeutic agents and GK01 excipients (e.g., dimethyl sulfoxide);
- Participation in a clinical trial within 28 days before signing the informed consent form;
- Receipt of extensive radiotherapy within 28 days before signing the ICF, except for radiotherapy administered locally for symptom relief to non-target lesions within 14 days before signing the ICF or anticipated during the study period;
- Major surgery within 28 days before signing the ICF (except endoscopic exploration for diagnostic purposes), or major surgery anticipated during the study period;
- At the time of signing the ICF, toxicities caused by prior antitumor therapy have not recovered to Grade 1 or baseline, except for alopecia and hyperpigmentation (according to NCI-CTCAE version 6.0);
- Any uncontrolled active infection at the time of signing the ICF or within 4 weeks before the first infusion that requires parenteral antibiotic, antiviral, or antifungal therapy;
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- Active or prior autoimmune disease with the potential for recurrence (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, and psoriasis), or at risk of such disease;
- A history of prior bone marrow or organ transplantation;
- Concurrent or prior history of interstitial lung disease or interstitial pneumonitis;
- A history of active pulmonary tuberculosis infection within 1 year before screening (except for participants with a history of active pulmonary tuberculosis infection more than 1 year previously who, as judged by the investigator, currently have no evidence of active pulmonary tuberculosis);
- A history of other primary malignant tumors within 5 years before study treatment;
- Clinically significant cardiovascular disease;
- A history of bleeding within 6 months before signing the ICF; clinically significant, evident bleeding risk or tendency (any bleeding or bleeding event of Grade ≥3 within 28 days before screening, including esophageal variceal bleeding);
- Metabolic disorders, such as poorly controlled diabetes mellitus (glycated hemoglobin ≥8.5%), or other non-malignant organ or systemic diseases or secondary reactions to cancer that may result in a higher medical risk and/or uncertainty in the assessment of survival;
- Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic central compression; or a prior history of CNS disease, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, and Parkinson disease;
- Concurrent obstruction;
- Receipt of a live attenuated/inactivated vaccine within 28 days before signing the ICF, or planned administration of a live attenuated/inactivated vaccine during the screening period;
- Requirement for systemic corticosteroids (at a dose equivalent to or higher than 10 mg/day prednisone) or other immunosuppressive therapy within 14 days before harvest or during the study;
- Participants who are positive for hepatitis B surface antigen (HBsAg) at screening must be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, participants with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection must be excluded; participants who are positive for hepatitis C virus (HCV) antibody; participants who are positive for human immunodeficiency virus (HIV) antibody; participants who are positive for cytomegalovirus (CMV) DNA; participants who are positive for Treponema pallidum-specific antibody;
- Complications or other conditions that, in the opinion of the investigator, may affect compliance with the protocol or render the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jun Zhang, +8613816423993, zj10977@rjh.com.cn
About this study
Official title: A Clinical Study of GK01 Cell Therapy in Patients With Gastric Cancer With Peritoneal Metastasis Safety Tolerability and Preliminary Efficacy
This study is a single-arm, open-label clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GK01 cell therapy in patients with gastric cancer and peritoneal metastasis.
- Conditions
- Gastric Cancer (GC)
- Being tested
- GK01 combination with nab-paclitaxel and S-1
- Keywords
- Peritoneal Metastasis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GK01 combination with nab-paclitaxel and S-1Drug
Intraperitoneal infusion of GK01 is planned after the second cycle of nab-paclitaxel plus S-1 (tegafur) chemotherapy (C2D21).At 6 weeks after the GK01 cell infusion, participants will continue to receive nab-paclitaxel plus S-1 (tegafur) chemotherapy until disease progression or intolerance.
| Study group | Role | What they receive |
|---|---|---|
| GK01 combination with chemotherapy | Experimental | Not described Receives: Drug: GK01 combination with nab-paclitaxel and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profiles
The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Measured: 1 year
Secondary outcomes (5)
Objective response rate (ORR)
Proportion of subjects achieving complete response (CR) and partial response (PR)
Measured: 1 year
Disease control rate (DCR)
Proportion of subjects achieving best response of CR, PR, or SD
Measured: 1 year
Duration of response (DOR)
Time from first documented evidence of confirmed CR or PR until the first documented evidence of disease progression or death, whichever occurs earlier
Measured: 1 year
6-month PFS rate
Defined as the proportion of patients who remain free from progression or death of the original cancer at 6 month.
Measured: 1 year
1-year OS rate
Defined as the proportion of patients who remain survival at 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923396
- Sponsor's protocol ID
- GK01IIT-RJYY01
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of GK01 Cell Therapy in Patients With Gastric Cancer With Peritoneal Metastasis Safety Tolerability and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT07923396
- Acronym / sponsor ID
- GK01IIT-RJYY01
- Conditions
- Gastric Cancer (GC)
- Keywords
- Peritoneal Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (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.
This study is a single-arm, open-label clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GK01 cell therapy in patients with gastric cancer and peritoneal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GK01 combination with chemotherapy | Experimental | Drug: GK01 combination with nab-paclitaxel and S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understands and voluntarily signs the informed consent form (ICF) before any study-related assessments/procedures are performed;
- Age ≥18 years at the time of signing the ICF;
- Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma, with no prior systemic therapy for locally advanced or metastatic gastric cancer (including targeted therapy, immunotherapy, and biologic therapy). If neoadjuvant or adjuvant therapy has been received, disease progression or recurrence must have occurred ≥6 months after the completion of neoadjuvant or adjuvant therapy.
- At least one lesion ;
- At least 1 measurable lesion (according to the RECIST 1.1 criteria);
Key exclusion criteria (20 listed)
- A history of severe allergy or hypersensitivity to any component of any drug to be used in this study, including but not limited to the planned chemotherapeutic agents and GK01 excipients (e.g., dimethyl sulfoxide);
- Participation in a clinical trial within 28 days before signing the informed consent form;
- Receipt of extensive radiotherapy within 28 days before signing the ICF, except for radiotherapy administered locally for symptom relief to non-target lesions within 14 days before signing the ICF or anticipated during the study period;
- Major surgery within 28 days before signing the ICF (except endoscopic exploration for diagnostic purposes), or major surgery anticipated during the study period;
- At the time of signing the ICF, toxicities caused by prior antitumor therapy have not recovered to Grade 1 or baseline, except for alopecia and hyperpigmentation (according to NCI-CTCAE version 6.0);
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 |
|---|---|---|
| GK01 combination with nab-paclitaxel and S-1Intraperitoneal infusion of GK01 is planned after the second cycle of nab-paclitaxel plus S-1 (tegafur) chemotherapy (C2D21).At 6 weeks after the GK01 cell infusion, participants will continue to receive nab-paclitaxel plus S-1 (tegafur) chemotherapy until disease progression or intolerance. | Drug | GK01 combination with chemotherapy |
Primary outcome
Safety profiles
Time frame: 1 year
The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
5 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Duration of response (DOR)
Time frame: 1 year
6-month PFS rate
Time frame: 1 year
1-year OS rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GK01 combination with nab-paclitaxel and S-1 in people with Gastric Cancer (GC), run by Ruijin Hospital 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 8 inclusion and 20 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang (+8613816423993, zj10977@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profiles (time frame: 1 year). 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 6 Nov 2026.