NCT06371586RecruitingPhase 2
Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC
Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer
Source: ClinicalTrials.gov · Last updated 17 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- First submitted
- 14 Apr 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06371586
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 67
- From 1 Mar 2024 to the primary completion date, 1 Mar 2027
- 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
- Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
- Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
Other illness
- Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
- Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
- Active infections that require systemic treatment;
- Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
- Individuals with a history of mental illness and poor compliance.
Other
- Those who cannot swallow pills;
- Interstitial pneumonia;
- Moderate to severe cirrhosis caused by any reason;
- Pregnant and lactating patients;
Who the study is looking for
- Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
- Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition);
- Has not received any anti-tumor treatment for gastric cancer yet;
- Age range from 18 to 75 years old;
- ECOG score 0-1 points;
- Liver and kidney function and blood routine meet the following conditions:
- Neutrophils\>1.5G/L, Hb\>90g/L, PLT\>100G/L; ALT and AST\<2.5ULN; TBIL\<1.5 ULN; Cr\<1.0ULN;
- Left ventricular ejection fraction\>60%;
- Good compliance and ability to accept long-term follow-up;
- Sign informed consent.
Age in the registry: 18 years to 75 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 |
|---|---|---|---|
| Cancer hospital，Chinese acadamy of medical sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.