Treatment for advanced gastric cancer with peritoneal metastasis using a combination of therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study investigates the efficacy of a treatment regimen combining Cadonilimab, LM-302, and S-1 with intraperitoneal infusion of paclitaxel for patients with Claudin 18.2-positive gastric cancer that has spread to the peritoneum. The approach aims to target specific cancer markers and enhance treatment effectiveness. Participants will receive these therapies to assess their impact on disease progression and patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;
2. Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;
3. Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);
4. Age ≥ 18 years at registration;
5. Eastern Cooperative Oncology Group (ECOG) score ≤ 1;
6. Expected life expectancy \> 3 months;
7. Adequate bone marrow, liver, and renal functions.

Exclusion Criteria:

1. Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
2. During pregnancy, within 28 days of post parturition, or during lactation;
3. Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.
4. Synchronous or metachronous (within 5 years) malignancies.
5. Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
6. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;
7. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
8. Known peripheral neuropathy (\> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;
9. Patients on steroid or immunosuppressant treatment after organ transplant;
10. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;
11. Moderate or severe renal damage \[creatinine clearance ≤ 50 ml/min\], or serum creatinine \> upper limit of normal (ULN), 115 μmol/L;
12. Known dihydropyrimidine dehydrogenase (DPD) deficiency;
13. Anaphylaxis to paclitaxel or any research drug ingredient.
14. Active autoimmune disease or history of refractory autoimmune disease;
15. Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
16. HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);
17. Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;
18. Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.

Where it's running

• Ruijin Hospital Shanghai Jiao Tong University School of Medicine
  Shanghai, Huangpu District, China Recruiting

Study contacts

• Study coordinator: Zhongyin Yang, PhD
• Email: jeffreyyong@163.com
• Phone: 8621-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LM-302 plus oral S-1 and intraperitoneal paclitaxel, with or without cadonilimab, for Claudin 18.2–positive advanced stomach or GEJ cancer with peritoneal spread

  This trial tests whether adding cadonilimab to LM-302, oral S-1, and intraperitoneal paclitaxel helps people with Claudin 18.2–positive gastric or gastroesophageal junction cancer that has spread to the peritoneum.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Huangpu District · NCT07556640

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum

  Aims to see if adding targeted radiotherapy and cadonilimab immunotherapy to standard second-line chemotherapy helps adults with colorectal cancer that’s spread only to the peritoneum.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07815834

• Cadonilimab with chemotherapy vs chemotherapy with/without nivolumab as first-line treatment for HER2-negative advanced gastric/GEJ cancer

  This study tests whether adding cadonilimab to chemotherapy helps people with newly diagnosed, unresectable or metastatic HER2-negative gastric/GEJ cancer live longer, compared with standard chemo alone (with or without nivolumab).

  Recruiting Phase 3 Akeso · Phoenix, Arizona and 24 other locations · NCT07700979

• Cadonilimab with chemotherapy for gastric or GEJ cancer

  This trial tests whether adding cadonilimab to standard chemotherapy is safe and effective for adults with locally advanced or resectable gastric or GEJ cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07631000

• Cadonilimab plus high-dose interferon in neoadjuvant treatment for stage III/IV melanoma

  This trial tests whether giving cadonilimab with high-dose interferon before surgery can shrink tumors in people with stage III or resectable stage IV melanoma and whether it is safe.

  Recruiting Early Phase 1 Xijing Hospital · Xi'an · NCT07586904

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.