Actively Recruiting
Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer
Led by Fudan University · Updated on 2023-11-08
55
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients. Participants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+/ISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.
CONDITIONS
Official Title
Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed adenocarcinoma of stomach or gastroesophageal junction (excluding Siewert type I).
- Limited metastatic disease as defined by specific lymph node and organ involvement.
- At least one evaluable lesion on CT or MRI according to RESIST 1.1 criteria.
- Known HER2 status.
- Confirmed pMMR/MSS status by immunohistochemistry or gene test.
- Male or female aged between 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Physical and organ function adequate to tolerate planned chemotherapy, immunotherapy, radiotherapy, and surgery.
- No previous surgery or antitumor treatments including chemotherapy, radiotherapy, or immunotherapy.
- Adequate blood counts and hematological function.
- Adequate liver function within specified limits.
- Adequate kidney function with serum creatinine and creatinine clearance within limits.
- Adequate coagulation function.
- Thyroid function within normal range or properly investigated.
- Urine protein less than 2+ or 24-hour urine protein less than 1g if higher.
- No serious concomitant disease and life expectancy over 6 months.
- Willingness to sign informed consent and comply with study protocol.
- Willingness to provide blood and tissue samples.
- Female patients not pregnant or breastfeeding and agree to use contraception during and after treatment.
You will not qualify if you...
- Previous surgery, chemotherapy, radiotherapy, or immunotherapy for gastric cancer.
- History of other cancers in the past 5 years except certain treated skin, bladder, cervical, or breast cancers.
- Pregnant, breastfeeding, or planning pregnancy; positive pregnancy test or no test during baseline.
- Sexual activity with potential for pregnancy without willingness to use contraception.
- Known allergies to study drugs including chemotherapy.
- History of stem cell or organ transplantation.
- Live vaccines within 28 days before recruitment.
- Immunotherapy or experimental treatments within 28 days before enrollment.
- Prior anti-PD-1, PD-L1, or checkpoint therapy.
- Recent use of steroids or immunosuppressive therapy beyond allowed exceptions.
- Significant weight loss (>20%) in last 2 months.
- Uncontrolled systemic diseases like diabetes or hypertension.
- Uncontrollable pleural, pericardial effusion, or ascites within 2 weeks before recruitment.
- Failure of major organs.
- Moderate to severe kidney injury or creatinine abnormality.
- Dipyrimidine dehydrogenase deficiency.
- Central nervous system disorders or brain metastases.
- Recent cerebrovascular accidents or peripheral neuropathy.
- Serious uncontrolled heart conditions within 6 months.
- Pulmonary embolism within 28 days before enrollment.
- History of serious pulmonary diseases.
- Recent or high risk of gastrointestinal bleeding or perforation.
- Gastrointestinal obstruction or malabsorption affecting oral drug intake.
- Inability to swallow or take oral medication.
- History of active or refractory autoimmune disease.
- Severe infections requiring systemic therapy.
- Known HIV infection.
- Untreated chronic hepatitis B or C infection.
- Alcohol or drug abuse or conditions interfering with study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
M
Menglong Zhou, MD
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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