Combining PD-1 antibody and chemotherapy followed by surgery for limited metastatic gastric cancer

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

The ROSETTE trial is an open-label, randomized phase II study aimed at evaluating treatment strategies for patients with limited metastatic gastric or gastroesophageal adenocarcinoma. Participants will be assigned to receive either a combination of systemic treatment, which includes immunotherapy and chemotherapy, followed by local surgical treatment, or systemic treatment alone. The study focuses on the effectiveness of a surgery-centric approach to manage both primary and metastatic tumors, with the primary goal of assessing the 1-year event-free survival rate. Secondary outcomes will include various measures of treatment response and survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men or women aged 18-79.
2. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status.
3. Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers.
4. Primary gastric cancer lesions are resectable, with limited distant metastases meeting the either of the following criteria: (1) condition (a) only; (2) any single condition from (b), with or without (a).

   (a) Non-regional intra-abdominal lymph node metastasis: Include metastasis to the superior mesenteric artery, middle colic artery, and para-aortic/retroperitoneal nodes (according to AJCC 8th edition standards).

   (b1) Localized peritoneal metastasis: P0CY1, P1a, or P1b, according to the Japanese Classification of Gastric Carcinoma (15th edition).

   (b2) Liver metastasis: Up to 5 metastatic lesions. (b3) Lung metastasis: Up to 5 unilateral metastatic lesions. (b4) Ovarian metastasis: Unilateral or bilateral. (b5) Adrenal metastasis: Unilateral or bilateral. (b6) Single-region extra-abdominal lymph node metastasis: Such as cervical, supraclavicular, or mediastinal lymph nodes.

   (b7) Bone metastasis limited to a single radiation field. (b8) Other limited metastases as determined by the research team.
5. No previous anti-tumor treatments.
6. ECOG score ≤2, no surgical contraindications.
7. Life expectancy ≥ 3 months.
8. Physical condition and organ function suitable for major abdominal surgery.
9. Willingness and ability to comply with the study protocol.
10. Fertile women with a negative urine or serum pregnancy test and agreement to use effective contraception during the study and for 180 days after the last dose. Non-sterilized men must also agree to use effective contraception.
11. Signed informed consent with an understanding that patients can withdraw anytime.

Exclusion Criteria:

1. Inability to tolerate oral chemotherapy.
2. Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.
3. Central nervous system metastasis and/or carcinomatous meningitis.
4. Allergy to any components of the study medication.
5. History of previous malignancies or concurrent other malignancies, with the exception of completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, and other tumors with no recurrence for at least 5 years.
6. Uncontrolled pleural effusion, pericardial effusion, or ascites.
7. Weight loss ≥20% within two months before enrollment.
8. Upper gastrointestinal obstruction or physiological dysfunction.
9. Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery.
10. Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy.
11. Systemic steroid or immunosuppressant use within 14 days before enrollment.
12. Live vaccine within four weeks prior to enrollment.
13. Uncontrolled systemic disease.
14. Active or past autoimmune diseases that may recur.
15. Severe chronic infections or active infections requiring systemic antibacterial, antifungal, or antiviral treatment.
16. History of lung disease.
17. Pregnancy, lactation, or planning for pregnancy.
18. HBsAg-positive with HBV DNA ≥500 IU/mL.
19. Positive HIV antibody.
20. Conditions that may impact study compliance or participation.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Zhongshan Hospital Fudan University
  Shanghai, Shanghai City, China Not yet recruiting

Study contacts

• Principal investigator: Xuefei Wang, MD, PhD — Fudan University
• Study coordinator: Xuefei Wang, MD, PhD
• Email: wang.xuefei@zs-hospital.sh.cn
• Phone: 0

Similar studies

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

• Evaluating zanidatamab for HER2-expressing tumors

  This study is testing a new drug called zanidatamab to see if it can help people with certain types of cancer that have high levels of HER2 and who have already tried other treatments without success.

  Recruiting at 30 sites Phase 2 Jazz Pharmaceuticals · Prescott, Arizona and 41 other locations · NCT06695845

• Testing MDX2001 for advanced solid tumors

  This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.

  Recruiting at 6 sites Phase 1/2 ModeX Therapeutics, An OPKO Health Company · Denver, Colorado and 5 other locations · NCT06239194

• Total neoadjuvant chemotherapy for advanced gastric and gastroesophageal cancer

  This study is testing two different chemotherapy plans for people with advanced stomach cancer to see which one helps them better tolerate treatment and successfully have surgery.

  Recruiting at 2 sites Phase 2/3 Ukrainian Society of Clinical Oncology · Vilnius and 1 other locations · NCT06028737

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

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.