SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer

NCT06266871 | Not Yet Recruiting Phase 1

• 1 other identifier: WCH-2023-1625
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy

  5 months after the last subject participating in

Secondary Outcomes (5)

• R0 resection rate

  5 months after the last subject participating in

• MPR rate

  5 months after the last subject participating in

• ORR

  5 months after the last subject participating in

• 2-year disease-free survival (DFS) rate

  every 3 month postoperation up to 24 months

• 2-year OS rate

  every 3 month postoperation up to 24 months

Study Arms (1)

SOX+Tislelizumab+LDRT

EXPERIMENTAL

Laparoscopic exploration is required in all patients to detect occult peritoneal metastases. All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w. Then, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes). After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab regimen. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab regimen. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles.

Drug: SOX+Tislelizumab+LDRT

Interventions

SOX+Tislelizumab+LDRT DRUG

All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles.

SOX+Tislelizumab+LDRT

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years.
• Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT3-T4a, N+, M0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
• Resectable G/GEJ cancer, as judged by experienced surgeons.
• Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1.
• Agree to provide blood, feces, and tissue specimens.
• The expected survival is longer than 3 months.
• There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects).
• Adequate organ and hematological function.
• Strict contraception.
• Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

You may not qualify if:

• Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
• Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
• Allergic to oxaliplatin, S-1, tislelizumab and similar drugs, or suspected allergies.
• With serious gastrointestinal diseases that affect the absorption of oral chemotherapy drugs, such as chronic inflammatory bowel disease.
• History of gastric perforation within 6 months.
• Clinical manifestations include significant arrhythmia, myocardial ischemia, severe atrioventricular block, heart failure, and severe heart valve disease; Or those with severe lung function impairment; Or those with impaired blood system, liver and kidney function who cannot tolerate radiotherapy and chemotherapy; Or severe bone marrow failure; Or those with uncontrollable infections.
• With uncontrollable mental illness.
• Pregnant or lactating women.
• Unable to comply with the research program or procedures.

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (1)

• Zhang PF, Chen Y, Li WK, Luo ZM, Chen J, Qian K, Chen XD, Wang MJ, Liu M. SOX combined with tislelizumab and low-dose radiation therapy for the neoadjuvant treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase Ib/II clinical trial. Front Immunol. 2024 Nov 13;15:1431957. doi: 10.3389/fimmu.2024.1431957. eCollection 2024.

  PMID: 39606219 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Mojin Wang, M.D.

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Ming Liu, M.D

CONTACT

+8618980606324; mingliu721@aliyun.com

Pengfei Zhang, M.D.

CONTACT

+8617828163584; fly_121988@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: March 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share