Actively Recruiting
Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-04-02
40
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.
CONDITIONS
Official Title
Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and willing to sign an approved consent form
- Age between 18 and 75 years, male or female
- Histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
- Advanced gastric cancer with para-aortic lymph node metastasis at initial treatment
- Primary tumor site treatable with D2 radical surgery
- Peritoneal exploration excluding peritoneal, liver, or other metastases
- Imaging showing only para-aortic lymph node metastasis as unresectable factor
- No prior anti-tumor treatments including radiotherapy, chemotherapy, targeted or immunotherapy
- At least one measurable lesion by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time greater than 3 months
- Adequate organ function meeting specified laboratory values for blood counts, liver, kidney, coagulation, and thyroid function
- Negative pregnancy test for women of childbearing potential
- Women of childbearing potential willing to use effective contraception during and after study
You will not qualify if you...
- HER-2 positive status
- Presence of peritoneal or other organ metastases
- Active gastrointestinal bleeding or history of gastrointestinal perforation or fistula within 6 months
- Other malignant diseases diagnosed within 5 years except certain skin cancers
- Participation in other clinical studies or treatments with investigational drugs within 4 weeks
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 or similar agents
- Recent treatment with systemic immunomodulatory or anti-tumor Chinese patent drugs within 2 weeks
- Active autoimmune disease requiring systemic treatment within 2 years
- Use of systemic glucocorticoids or immunosuppressive therapy within 7 days before first dose
- History of allogeneic organ or stem cell transplantation (except corneal transplant)
- Known allergy to Sintilimab, Oxaliplatin, S-1 or their excipients
- Conditions affecting oral drug intake such as inability to swallow or gastrointestinal obstruction
- Not fully recovered from previous treatment toxicities or complications
- HIV infection
- Uncontrolled active hepatitis B or active hepatitis C infection
- Vaccination with live vaccine within 30 days before first administration
- Pregnant or nursing women
- Serious or uncontrolled systemic diseases including major heart rhythm abnormalities, unstable angina, recent arterial thrombosis or embolism, uncontrolled blood pressure, active interstitial lung disease or pneumonia, active pulmonary tuberculosis, active infections, active diverticulitis or gastrointestinal obstruction, liver diseases, poor diabetes control, significant proteinuria, mental disorders preventing cooperation
- Other acute or chronic diseases or abnormal labs that increase study risk or interfere with results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
Y
Yan Yang
CONTACT
D
Dongdong Gu
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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