Actively Recruiting
Neoadjuvant Sintilimab Combined with Weekly Metronomic PLOF Chemotherapy for Resectable Locally Advanced Gastric Cancer A Phase II Study
Led by Huashan Hospital · Updated on 2024-12-30
50
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a neoadjuvant treatment combining Sintilimab with a weekly metronomic chemotherapy regimen called PLOF in patients with resectable locally advanced gastric cancer. This phase II, single-arm clinical study will include 50 patients diagnosed with advanced gastric adenocarcinoma meeting specific tumor and lymph node staging criteria. The aim is to assess tumor response and survival outcomes following this combined treatment approach. Participants will receive neoadjuvant therapy consisting of six weekly doses of the PLOF chemotherapy regimen (paclitaxel, oxaliplatin, and 5-fluorouracil) alongside two intravenous doses of Sintilimab given every three weeks before surgery. Those with tumors deemed resectable will undergo radical surgery and then receive six additional postoperative cycles of PLOF chemotherapy plus two more doses of Sintilimab as adjuvant therapy. This treatment period lasts approximately six weeks before and after surgery. During the study, patients will have imaging assessments every three months after surgery to monitor for disease recurrence and survival follow-up every three months after any recurrence. Researchers will measure outcomes such as the percentage of patients with no residual tumor cells or minimal tumor cell survival in surgical specimens, response rates, disease control, progression-free survival at two years, overall survival at three years, and treatment safety. Participants will be observed during treatment, for 30 days after treatment ends, and followed for up to five years postoperatively to evaluate long-term outcomes and immune effects.
CONDITIONS
Official Title
Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (PLOF) for Resectable Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form
- Male or female aged 18 years or older
- Histologically confirmed gastric adenocarcinoma diagnosed as locally advanced (cT3-4aN1-3M0) and resectable
- No prior systemic therapy including surgery, radiotherapy, or immunotherapy for this disease
- Consent to radical surgery with no contraindications as determined by the surgeon
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Expected survival greater than 6 months
- Adequate organ function meeting specified laboratory criteria including blood counts, liver and kidney function, coagulation, thyroid function, and myocardial enzymes
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception if at risk of pregnancy
You will not qualify if you...
- Active bleeding from gastric lesion observed endoscopically
- Participation in another interventional clinical study or use of investigational drugs/devices within 4 weeks prior to first dosing
- Prior therapy with immune checkpoint inhibitors or agents targeting CTLA-4 or related pathways
- Diagnosis of another malignancy within 5 years prior to first treatment dose
- Active autoimmune disease requiring systemic therapy within 2 years prior to treatment
- Live vaccination within 30 days before starting treatment
- Recent use of Chinese proprietary medicines with antitumor or immunomodulatory effects within 2 weeks prior to treatment
- Use of systemic glucocorticoids or immunosuppressive therapy within 7 days before treatment
- Incomplete recovery from prior treatment-related toxicities except fatigue or hair loss
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal transplant)
- Known allergy to study drugs
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Pregnant or breastfeeding women
- Serious or uncontrolled systemic diseases
- Any other condition that may affect study outcomes as judged by the investigator
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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