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New treatment option for Gastric Cancer
Official title Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
ClinicalTrials.gov ID: NCT06468280
What this study is testing
What is PD-1 Monoclonal Antibody?
PD-1 Monoclonal Antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ROSETTE trial is an open-label, randomized phase II study designed to investigate treatment strategies for patients with limited metastatic gastric or gastroesophageal adenocarcinoma. Eligible patients are randomized to receive either systemic treatment followed by surgeon-led local treatment, or systemic treatment alone.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Men or women aged 18-79.
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression...
- Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended...
- Primary gastric cancer lesions are resectable, with limited distant metastases meeting the either of the following criteria: (1) condition (a) only...
- No previous anti-tumor treatments.
You likely can't join if
- Inability to tolerate oral chemotherapy.
- Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.
- Central nervous system metastasis and/or carcinomatous meningitis.
- Allergy to any components of the study medication.
- History of previous malignancies or concurrent other malignancies, with the exception of completely resected basal cell or squamous cell skin cancer...
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
See the full eligibility criteria
- Men or women aged 18-79.
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status.
- Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers.
- 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)...
- No previous anti-tumor treatments.
- ECOG score ≤2, no surgical contraindications.
- Life expectancy ≥ 3 months.
- Physical condition and organ function suitable for major abdominal surgery.
- Willingness and ability to comply with the study protocol.
- 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...
- Signed informed consent with an understanding that patients can withdraw anytime.
- Inability to tolerate oral chemotherapy.
- Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.
- Central nervous system metastasis and/or carcinomatous meningitis.
- Allergy to any components of the study medication.
- 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...
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Weight loss ≥20% within two months before enrollment.
- Upper gastrointestinal obstruction or physiological dysfunction.
- Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery.
- Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy.
- Systemic steroid or immunosuppressant use within 14 days before enrollment.
- Live vaccine within four weeks prior to enrollment.
- Uncontrolled systemic disease.
- Active or past autoimmune diseases that may recur.
- Severe chronic infections or active infections requiring systemic antibacterial, antifungal, or antiviral treatment.
- History of lung disease.
- Pregnancy, lactation, or planning for pregnancy.
- HBsAg-positive with HBV DNA ≥500 IU/mL.
- Positive HIV antibody.
- Conditions that may impact study compliance or participation.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai City, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai City, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.