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Sensitive prediction of protein profiling in chemotherapy combined with immunotherapy for advanced gastric cancer: A multi-institutional prospective real-world study

Sensitive prediction of protein profiling in chemotherapy combined with immunotherapy for advanced gastric cancer: A multi-institutional prospective real-world study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061007
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-11
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Gastric cancer

Interventions

Gold Standard:The effect of immunotherapy and chemotherapy by abdominal enhanced CT (according to RECIST V1.1 standard)
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Sponsors

Department of General Surgery, The Chinese PLA General Hospital First Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with clinically and pathologically confirmed advanced gastric adenocarcinoma; 2. Aged 18-80 years; 3. According to AJCC/UICC 8: Preoperative clinical stage II to IV (CT2-4BN0-3M0-1); 4. Immunohistochemical results showed non-HER-2 positive; 5. ASA score <= III; 6. Informed consent of patients; 7. Eastern Cooperative tumor Group (ECOG) score 0-1; 8. Enough organ function can tolerate immunotherapy.

Exclusion criteria

Exclusion criteria: 1. Severe mental disorders; 2. Women who are pregnant or breastfeeding; 3. Patients with gastric stump cancer and other benign and malignant tumors; 4. Prior neoadjuvant or adjuvant chemoradiotherapy or immunotherapy was performed; 5. Immunohistochemistry showed positive HER-2; 6. Untreated peripheral neuropathy with CNS metastasis (> level 1); 7. Having or suspected of having an autoimmune disease; 8. Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.

Design outcomes

Primary

MeasureTime frame
Objective response rate after the second treatment period;

Secondary

MeasureTime frame
Objective response rate after fourth treatment period;Pathological complete response rate;3 year overall survival rate;3 year disease-free survival rate;Disease control rate;3 year progess-free survival rate;

Countries

China

Contacts

Public ContactWei Bo

Department of General Surgery, The Chinese PLA General Hospital First Medical Center l

weibo@vip.163.com+86 13910038055

Outcome results

None listed

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