Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgery-centric Local Treatment in Patients with Limited-metastatic Gastric Cancer (ROSETTE)
NCT ID: NCT06468280
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2024-11-08
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Local Treatment Arm (Arm A)
In Phase 1, patients will receive four cycles of PD-1 antibody in combination with XELOX chemotherapy. Following this phase, a radiologic assessment will evaluate disease progression status. Patients identified as not experiencing progression will proceed with the study treatments. Subsequently, they will undergo surgeon-led local treatment, which may include standard D2 gastrectomy and metastasectomy when feasible. Non-surgical local treatments may also be administered to address unresected or unresectable metastatic lesions, either concurrently or sequentially with surgery. After surgical intervention, patients will receive up to four additional cycles of XELOX chemotherapy, followed by maintenance therapy consisting of tislelizumab and capecitabine during Phase 2 of the systemic treatment. The total treatment duration may extend up to two years from the date of enrollment.
Local treatment (Surgical)
Radical gastrectomy with standard D2 lymphadenectomy will be performed, along with radical surgery for resectable metastatic lesions.
PD-1 Monoclonal Antibody
PD-1 monoclonal antibody will be administered at a dosage of 200 mg via intravenous infusion, once every cycle, each cycle spanning three weeks. The specific PD-1 antibody used will be determined by the investigators based on clinical considerations. Potential options include Sintilimab, Toripalimab, Nivolumab, Tislelizumab, or other approved PD-1 antibody products indicated for the treatment of metastatic gastric or gastroesophageal adenocarcinoma.
XELOX Chemotherapy Regimen
Oxaliplatin: 130 mg/m² administered via a 3-hour intravenous infusion on D1 of each 3-week cycle.
Capecitabine: 1000 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle.
Local Treatment (Non-surgical)
Additional local treatment for unresected metastatic lesions during phase 2 systemic therapy is permitted, including:
* Bone metastasis, distant lymph nodes, adrenal metastasis: Radiation therapy.
* Lung and liver metastasis: Radiofrequency ablation, interventional embolization, or radiation therapy.
* Peritoneal metastasis: Hyperthermic intraperitoneal chemotherapy (HIPEC).
* Other metastatic lesions: Non-surgical treatment options discussed by the multidisciplinary team.
Systemic Treatment Arm (Arm B)
In Phase 1, patients will receive four cycles of PD-1 antibody in conjunction with XELOX chemotherapy. Following this phase, a radiologic assessment will evaluate the disease progression status. Patients classified as not experiencing progression-defined as the absence of local progression, advancement of existing distant metastases, or the emergence of new distant metastatic lesions-will continue with the study treatments. In Phase 2, participants will receive an additional up to four cycles of PD-1 antibody and XELOX chemotherapy, followed by maintenance therapy consisting of PD-1 antibody and capecitabine. The total treatment duration could extend up to two years from the date of enrollment.
PD-1 Monoclonal Antibody
PD-1 monoclonal antibody will be administered at a dosage of 200 mg via intravenous infusion, once every cycle, each cycle spanning three weeks. The specific PD-1 antibody used will be determined by the investigators based on clinical considerations. Potential options include Sintilimab, Toripalimab, Nivolumab, Tislelizumab, or other approved PD-1 antibody products indicated for the treatment of metastatic gastric or gastroesophageal adenocarcinoma.
XELOX Chemotherapy Regimen
Oxaliplatin: 130 mg/m² administered via a 3-hour intravenous infusion on D1 of each 3-week cycle.
Capecitabine: 1000 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle.
Interventions
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Local treatment (Surgical)
Radical gastrectomy with standard D2 lymphadenectomy will be performed, along with radical surgery for resectable metastatic lesions.
PD-1 Monoclonal Antibody
PD-1 monoclonal antibody will be administered at a dosage of 200 mg via intravenous infusion, once every cycle, each cycle spanning three weeks. The specific PD-1 antibody used will be determined by the investigators based on clinical considerations. Potential options include Sintilimab, Toripalimab, Nivolumab, Tislelizumab, or other approved PD-1 antibody products indicated for the treatment of metastatic gastric or gastroesophageal adenocarcinoma.
XELOX Chemotherapy Regimen
Oxaliplatin: 130 mg/m² administered via a 3-hour intravenous infusion on D1 of each 3-week cycle.
Capecitabine: 1000 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle.
Local Treatment (Non-surgical)
Additional local treatment for unresected metastatic lesions during phase 2 systemic therapy is permitted, including:
* Bone metastasis, distant lymph nodes, adrenal metastasis: Radiation therapy.
* Lung and liver metastasis: Radiofrequency ablation, interventional embolization, or radiation therapy.
* Peritoneal metastasis: Hyperthermic intraperitoneal chemotherapy (HIPEC).
* Other metastatic lesions: Non-surgical treatment options discussed by the multidisciplinary team.
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status.
3. HER2-negative gastric cancer, confirmed by HER2 immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).
4. Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers.
5. 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) (21).
(b1) Localized peritoneal metastasis: P0CY1, P1a, or P1b, according to the Japanese Classification of Gastric Carcinoma (15th edition) (22).
(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.
6. No previous anti-tumor treatments.
7. ECOG score ≤2, no surgical contraindications.
8. Life expectancy ≥ 3 months.
9. Physical condition and organ function suitable for major abdominal surgery.
10. Willingness and ability to comply with the study protocol.
11. 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.
12. Signed informed consent with an understanding that patients can withdraw anytime.
Exclusion Criteria
2. Inability to tolerate oral chemotherapy.
3. Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.
4. Central nervous system metastasis and/or carcinomatous meningitis.
5. Allergy to any components of the study medication.
6. 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.
7. Uncontrolled pleural effusion, pericardial effusion, or ascites.
8. Weight loss ≥20% within two months before enrollment.
9. Upper gastrointestinal obstruction or physiological dysfunction.
10. Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery.
11. Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy.
12. Systemic steroid or immunosuppressant use within 14 days before enrollment.
13. Live vaccine within four weeks prior to enrollment.
14. Uncontrolled systemic disease.
15. Active or past autoimmune diseases that may recur.
16. Severe chronic infections or active infections requiring systemic antibacterial, antifungal, or antiviral treatment.
17. History of lung disease.
18. Pregnancy, lactation, or planning for pregnancy.
19. HBsAg-positive with HBV DNA ≥500 IU/mL.
20. Positive HIV antibody.
21. Conditions that may impact study compliance or participation.
18 Years
79 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Xuefei.Wang
Chief of Gastrointestinal Surgery Department
Principal Investigators
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Xuefei Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital Fudan University
Shanghai, Shanghai City, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xuefei Wang, MD, PhD
Role: primary
Xuefei Wang, MD, PhD
Role: backup
Xuefei Wang
Role: primary
References
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Wu YY, Lee LC, Zeng H, Gu Y, Xu C, Chen WD, Shen ZB, Shen KT, Cui YH, Sun YH, Liu TS, Tang ZQ, Wang XF. Synergistic effects of PD-1 antibody and chemotherapy followed by surgery-centric local treatment in patients with limited-metastatic gastric or gastroesophageal adenocarcinoma (ROSETTE trial): an open-label, single-center, randomized phase 2 trial. BMC Cancer. 2025 Jun 1;25(1):981. doi: 10.1186/s12885-025-14331-5.
Other Identifiers
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KY2024164
Identifier Type: -
Identifier Source: org_study_id