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A prospective real-world study of conversion therapy alone for gastric cancer patients with liver metastasis

A single-center, prospective real-world study of conversion therapy alone versus conversion plus surgery for gastric cancer patients with liver metastasis

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082912
Enrollment
Unknown
Registered
2024-04-10
Start date
2024-04-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Platinum + fluorouracil:Platinum + fluorouracil regimen (taking S-1 plus oxaliplatin (SOX) regimen as an example) : S-1 40-60mg BID d1-14,q3
PD-1 inhibitor regimen:PD-1 inhibitor regimen (take tislelizumab as an example) : 200mg, q3w, is recommended based on RATIONALE 305, and moderate adjustment can be made based on patient tolerance
The trastuzumab regimen:for patients with HER-2 amplification status (HER2+,ISH+/HER3+), trastuzumab was added: a loading dose of 8 mg/kg iv drip for 90 min was recommended
The maintenance dose was 6 mg/kg iv drip for 30-90 min, q3w. If the treatment is delayed or interrupted, the delay time is less than 1 week, the maintenance dose can be used directly. If the delay tim

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Patients with clinically and pathologically confirmed advanced gastric adenocarcinoma ? Age: 18 years old = age =80 years old ? According to the AJCC/UICC 8th edition: preoperative clinical stage IVB (cT2-4bN0-3M1), only liver metastases (imaging examination can be evaluated) ?ASA score = grade ? ? Eastern Cooperative Oncology Group (ECOG) score 0-1 ? sufficient organ function to tolerate immunotherapy and chemotherapy ? Informed consent of patients

Exclusion criteria

Exclusion criteria: ? Severe mental disorders (2) pregnant or lactating women ? Gastric stump cancer and other benign and malignant gastric tumors ? prior neoadjuvant or adjuvant chemoradiotherapy or immunotherapy ? Central nervous system metastasis untreated peripheral neuropathy (> grade 1) ? patients with or suspected of having autoimmune diseases ? Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc (8) Active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA class ?-?

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Disease control rate;Surgical conversion rate;R0 resection rate;Major pathological response rate;

Countries

China

Contacts

Public ContactWei Zhao

the First Affiliated Hospital of Xi'an Jiaotong University

zhaowei9803@126.com+86 152 9169 8780

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026