The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction

Phase 2

Not yet recruiting

• Conditions: Immunotherapy Gastroesophageal Junction
• Interventions: Drug: Tislelizumab; Drug: Anlotinib; Drug: Oxaliplatin; Drug: Tegafur

• Registration Number: NCT06396585
• Lead Sponsor: Fujian Cancer Hospital

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Status Verified: 2024-05
• Study First Posted: 2024-05-02
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Start: 2024-08-01
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab combined with anlotinib chemotherapy	Tislelizumab	-
Tislelizumab combined with anlotinib chemotherapy	Anlotinib	-
Tislelizumab combined with anlotinib chemotherapy	Oxaliplatin	-
Tislelizumab combined with anlotinib chemotherapy	Tegafur	-

Primary Outcome Measures

Name	Time	Method
Pathological complete response	4 weeks after surgery	Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Secondary Outcome Measures

Name	Time	Method
Major pathological response	4 weeks after surgery	Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Objective Response Rate (ORR)	At the end of Cycle 3 (each cycle is 21 days)	Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

Trial Locations

Locations (1)

Fujian cancer hospital; 🇨🇳 Fuzhou, Fujian, China