NCT05975749RecruitingPhase 2
Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
A Study of Compared Adjuvant Serplulimab and Trastuzuma and Chemotherapy vs Chemotherapy Only in Her-2 Positive Gastric Cancer With II-III Stage Following Curative Resection
Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 27 Jul 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05975749
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 114
- From 1 Jan 2023 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unavailable for R0 resection and D2 lymph node dissection.
Other illness
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- History of chemotherapy, radiotherapy, immunotherapy or target therapy.
Other
- Patients with stage I and IV.
- Multiple primary tumors
Who the study is looking for
- Lower age limit of research subjects 20 years old and upper age limit of 80 years old.
- Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
- R0 gastrectomy with D2 lymphadenectomy
- Her2+ diagnosed by Immunohistochemistry or FISH
- ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
- No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.