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

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-08-31

Brief Summary

To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer

Conditions

Immunotherapy Gastroesophageal Junction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab combined with anlotinib chemotherapy

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W

Anlotinib

Intervention Type: DRUG

Participants will receive anlotinib,12mg, qd，d1-d14，Q3W

Oxaliplatin

Intervention Type: DRUG

Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W

Tegafur

Intervention Type: DRUG

Participants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W

Interventions

Tislelizumab

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W

Intervention Type: DRUG

Anlotinib

Participants will receive anlotinib,12mg, qd，d1-d14，Q3W

Intervention Type: DRUG

Oxaliplatin

Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W

Intervention Type: DRUG

Tegafur

Participants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian cancer hospital

Fuzhou, Fujian, China

Countries

China

Central Contacts

Ye Zai sheng, Doctor

Role: CONTACT

flyingengel@sina.cn

13950203076 ext. 86

Facility Contacts

Ye Zai sheng, doctor

Role: primary

flyingengel@sina.cn

13950203076

Other Identifiers

TASTE Trial

Identifier Type: -

Identifier Source: org_study_id