Actively Recruiting
A Phase II Study of TACE Plus PD-1 Antibody in the Locally Advanced Stomach Adenocarcinoma
Led by Shanghai Zhongshan Hospital · Updated on 2024-05-23
71
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase II, prospective, single-center, single-arm trial to evaluate the efficacy and safety of the combination of neoadjuvant transcatheter arterial chemoembolization (TACE) and PD-1 antibody Tislelizumab in the locally advanced stomach adenocarcinoma. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACE plus Tislelizumab. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.
CONDITIONS
Official Title
A Phase II Study of TACE Plus PD-1 Antibody in the Locally Advanced Stomach Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 75 years old
- KPS score ≥80
- Pathologically diagnosed gastric adenocarcinoma
- Clinical staging cT3/4aN+M0 based on imaging and laparoscopy
- At least one evaluable lesion on abdominal CT/MRI
- Lesion judged resectable by participating surgeons
- Physical condition allowing surgery
- Blood routine and biochemical indexes meet standards within 7 days before enrollment
- No serious concomitant diseases reducing survival time below 5 years
- Female participants with fertility are not pregnant or breastfeeding
- Willing and able to comply with study plan and follow-up procedures
You will not qualify if you...
- Signs of distant metastasis or unresectable local factors
- Allergy to contrast agents
- Prior cytotoxic chemotherapy, radiotherapy, immunotherapy, or radical surgery for this gastric cancer (except corticosteroids)
- Active or history of autoimmune diseases with risk of relapse
- Active malignant tumors within 2 years except specified cancers or cured localized recurrences
- Uncontrollable pleural, pericardial effusion or ascites requiring frequent drainage within 14 days
- Gastrointestinal bleeding within 2 weeks or high bleeding risk
- Gastrointestinal perforation or fistula within 6 months
- Upper gastrointestinal obstruction or malabsorption syndrome affecting drug absorption
- Weight loss ≥20% within 2 months
- History of lung diseases such as interstitial lung disease or pulmonary fibrosis
- Uncontrolled systemic diseases like diabetes or hypertension
- Severe or active infections requiring systemic therapy
- Untreated chronic hepatitis B or high HBV DNA levels, or positive hepatitis C RNA
- Cardiovascular risk factors as per study guide
- Known peripheral nerve disease grade ≥1 (except loss of deep tendon reflex only)
- Moderate or severe renal damage
- Known dihydropyrimidine dehydrogenase deficiency
- Allergy to any study drug ingredients
- Previous allogeneic stem cell or organ transplantation
- Systemic corticosteroids or immunosuppressives within 14 days before enrollment
- Live vaccines within 4 weeks before enrollment (seasonal flu vaccines allowed)
- Immunotherapy or trial treatment within 28 days or 5 half-lives before enrollment
- Palliative radiotherapy within 14 days before enrollment
- Previous anti-PD-1/PD-L1/PD-L2 or related antibody therapy
- Major surgery within 28 days before enrollment unless minimally invasive
- History of uncontrolled epilepsy, CNS disease, or mental disorder affecting consent or compliance
- Potential medical conditions or substance abuse affecting drug administration or safety interpretation
AI-Screening
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Trial Site Locations
Total: 1 location
1
ZhongShan hospital Fudan university
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhaoqing Tang, MD, phD
CONTACT
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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