Gastric Cancer Stage IVPhase 2NCT07556640
LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study
A Phase 2 study testing LM-302, S-1, paclitaxel and LM-302, Cadonilimab, S-1, paclitaxel in people with Gastric Cancer Stage IV and Peritoneal Metastases From Gastric Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma
- What is being tested?
- LM-302, S-1, paclitaxel and LM-302, Cadonilimab, S-1, paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to 30 Apr 2029
- Phase
- Phase 2
- 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
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
- Age ≥ 18 years at registration;
- Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;
- Claudin 18.2 positive (≥ 25%, moderate to strong staining);
- Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
- Expected life expectancy > 3 months;
- Adequate bone marrow, liver, and renal functions.
Who cannot join
- Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
- Pregnant or breastfeeding women;
- Prior treatment with Claudin 18.2 targeted therapy;
- History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
- History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing informed consent or compliance with oral medication.
- Clinically significant active heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medication, or myocardial infarction within the past 12 months;
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- Upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect S 1 absorption;
- Known peripheral neuropathy ≥ NCI CTC AE grade 1. However, patients with loss of deep tendon reflexes (DTR) alone may be included;
- Organ transplantation requiring immunosuppressive therapy;
- Severe uncontrolled recurrent infection or other severe uncontrolled concomitant diseases;
- Moderate or severe renal impairment (creatinine clearance ≤ 50 ml/min) or serum creatinine above the upper limit of normal;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Active hepatitis (for hepatitis B: HBsAg positive and HBV DNA ≥ 500 IU/ml; for hepatitis C: HCV antibody positive and HCV viral load > upper limit of normal);
- Psychiatric disorder that makes the patient unable to comply with treatment;
- Allergy to paclitaxel or any component of the study drugs;
- History or evidence of any disease, condition, treatment, or laboratory abnormality that could interfere with the study results or the patient's full participation, or any other condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.
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, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Huangpu District, 200025
13564877661, zyyang@shsmu.edu.cn
About this study
Official title: LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis: a Prospective, Exploratory Study
In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.
- Conditions
- Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma
- Being tested
- LM-302, S-1, paclitaxel, LM-302, Cadonilimab, S-1, paclitaxel
- Keywords
- Gastric cancer, Peritoneal metastasis, Claudin 18.2, Cadonilimab, Paclitaxel, Gastric or Esophagogastric Junction Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-302, S-1, paclitaxelDrug
LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.
LM-302, Cadonilimab, S-1, paclitaxelDrug
LM-302 2.0 mg/kg, Cadonilimab 10mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w.
| Study group | Role | What they receive |
|---|---|---|
| LM-302 and S-1 Plus Intraperitoneal Paclitaxel | Experimental | Not described Receives: Drug: LM-302, S-1, paclitaxel |
| LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab | Active comparator | Not described Receives: Drug: LM-302, Cadonilimab, S-1, paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival rate
Measured: up to 24 months
Secondary outcomes (6)
treatment related adverse events
Measured: up to 24 months
Progressive free survival (PFS)
Progression-free survival (PFS) is defined as the time from enrollemnt to disease progression or death from any cause.
Measured: up to 36 months
Overall survival (OS)
Measured: up to 36 months
Disease control rate (DCR)
Measured: up to 24 months
Objective response rate (ORR)
ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1 criteria.
Measured: up to 24 months
Major Pathological Response (MPR) rate
Defined as tumor specimens resected after conversion surgery with residual tumor cells ≤10%
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start17 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer Stage IVStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongyin Yang, MD., PhD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556640
- Sponsor's protocol ID
- DRAGON-17
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis: a Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT07556640
- Acronym / sponsor ID
- DRAGON-17
- Conditions
- Gastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma
- Keywords
- Gastric cancer, Peritoneal metastasis, Claudin 18.2, Cadonilimab, Paclitaxel, Gastric or Esophagogastric Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 29 Apr 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.
In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-302 and S-1 Plus Intraperitoneal Paclitaxel | Experimental | Drug: LM-302, S-1, paclitaxel |
| LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab | Active comparator | Drug: LM-302, Cadonilimab, S-1, paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
- Age ≥ 18 years at registration;
- Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;
- Claudin 18.2 positive (≥ 25%, moderate to strong staining);
- Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
Key exclusion criteria (16 listed)
- Presence of distant metastases other than peritoneal metastasis at the time of enrollment;
- Pregnant or breastfeeding women;
- Prior treatment with Claudin 18.2 targeted therapy;
- History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;
- History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing informed consent or compliance with oral medication.
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 |
|---|---|---|
| LM-302, S-1, paclitaxelLM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w. | Drug | LM-302 and S-1 Plus Intraperitoneal Paclitaxel |
| LM-302, Cadonilimab, S-1, paclitaxelLM-302 2.0 mg/kg, Cadonilimab 10mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1: BSA<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w. | Drug | LM-302 and S-1 Plus Intraperitoneal Paclitaxel combined with Cadonilimab |
Primary outcome
1-year survival rate
Time frame: up to 24 months
6 secondary outcomes
treatment related adverse events
Time frame: up to 24 months
Progressive free survival (PFS)
Time frame: up to 36 months
Overall survival (OS)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 24 months
Objective response rate (ORR)
Time frame: up to 24 months
Major Pathological Response (MPR) rate
Time frame: up to 24 months
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 29 Apr 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 2 study testing LM-302, S-1, paclitaxel and LM-302, Cadonilimab, S-1, paclitaxel in people with Gastric Cancer Stage IV and Peritoneal Metastases From Gastric Cancer, 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 Apr 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 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?
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 Zhongyin Yang (8621-64370045, jeffreyyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year survival rate (time frame: up to 24 months). 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 Apr 2026.