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Trial Title:
The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction
NCT ID:
NCT06396585
Condition:
Immunotherapy Gastroesophageal Junction
Conditions: Official terms:
Adenocarcinoma
Oxaliplatin
Tislelizumab
Tegafur
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1
,Q3W
Arm group label:
Tislelizumab combined with anlotinib chemotherapy
Intervention type:
Drug
Intervention name:
Anlotinib
Description:
Participants will receive anlotinib,12mg, qd，d1-d14，Q3W
Arm group label:
Tislelizumab combined with anlotinib chemotherapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W
Arm group label:
Tislelizumab combined with anlotinib chemotherapy
Intervention type:
Drug
Intervention name:
Tegafur
Description:
Participants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W
Arm group label:
Tislelizumab combined with anlotinib chemotherapy
Summary:
To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX
regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female and male patient ≥ 18 and ≤ 75 years.
- Histologically confirmed, medically operable, resectable adenocarcinoma of the
gastroesophageal junction (AEG, Siewert II-III)，uT3, uT4a, uT4b any N category, M0,
or any T N+ M0 patient
- ECOG≤1
- No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was
performed.
- Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone
scan or MRI (if bone metastases are suspected due to clinical signs).
- Preoperative endoscopic examination confirmed no positive peritoneal implantation
metastasis and exfoliated cells.
- The expected survival time is more than 6 months.
- Women of childbearing age shall be those who agree to use contraception (such as
intrauterine devices, contraceptives or condoms) during the study and for 6 months
after the end of the study; those who have a negative serum or urine pregnancy test
within 7 days before study enrollment and must be non-lactating; and men who agree
to use contraception during the study and for 6 months after the end of the study.
- Hematological, hepatic and renal function parameters adequate to allow surgical
procedure and chemotherapy
- Patient able and willing to provide written informed consent and to comply with the
study protocol and with the planned surgical procedures
Exclusion Criteria:
- Diagnosis of malignant diseases other than gastric cancer within 5 years prior to
first administration (excluding radical basal cell carcinoma of the skin, squamous
carcinoma of the skin, and/or radical resectable carcinoma in situ).
- Significant clinical bleeding symptoms or clear bleeding tendency, such as
gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred
within 3 months before enrollment. If fecal occult blood was positive at baseline,
reexamination could be performed, if it was still positive after reexamination,
gastroscopy was required.
- Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target
another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- A history of immunodeficiency, including HIV testing positive.
- Is currently participating in an interventional clinical study or has been treated
with another study drug or study device in the 4 weeks prior to initial dosing.
- Patients who had a history of cardiovascular and cerebrovascular diseases and were
still taking thrombolytic drugs or anticoagulants orally.
- HER2 positive is known.
- Patients with previous gastrointestinal perforation, abdominal abscess or recent
intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting
intestinal obstruction.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian cancer hospital
Address:
City:
Fuzhou
Zip:
350500
Country:
China
Contact:
Last name:
Ye Zai sheng, doctor
Phone:
13950203076
Email:
flyingengel@sina.cn
Start date:
August 1, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06396585
