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

NCT06396585 | Not Yet Recruiting Phase 2

• 1 other identifier: TASTE Trial
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

  4 weeks after surgery

Secondary Outcomes (2)

• Major pathological response

  4 weeks after surgery

• Objective Response Rate (ORR)

  At the end of Cycle 3 (each cycle is 21 days)

Study Arms (1)

Tislelizumab combined with anlotinib chemotherapy

EXPERIMENTAL

Drug: Tislelizumab; Drug: Anlotinib; Drug: Oxaliplatin; Drug: Tegafur

Interventions

Tislelizumab DRUG

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

Tislelizumab combined with anlotinib chemotherapy

Anlotinib DRUG

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

Tislelizumab combined with anlotinib chemotherapy

Oxaliplatin DRUG

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

Tislelizumab combined with anlotinib chemotherapy

Tegafur DRUG

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

Tislelizumab combined with anlotinib chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian cancer hospital

Fuzhou, Fujian, 350500, China

Location

MeSH Terms

Interventions

tislelizumab; anlotinib; Oxaliplatin; Tegafur

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ye Zai sheng, Doctor

CONTACT

13950203076; flyingengel@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: August 1, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)