Back to results

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma

Primary Purpose

Locally Advanced Gastric Adenocarcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tislelizumab combined with Oxaliplatin and Capecitabine

About this trial

This is an interventional treatment trial for Locally Advanced Gastric Adenocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Voluntarily sign the informed consent;
Aged 18-80 (including 18 and 80), both sexes;
Karnofsky score ≥70, ECOG score ≤1;
Clinical stage Ⅲ locally advanced gastric cancer (cT3-4a N+ M0, stage cIII) confirmed by basic ultrasound gastroscopy, enhanced CT/MRI or diagnostic laparoscopy;
Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
Radiographic evidence during the screening period showed at least one measurable and/or evaluable lesion according to RECIST1.1 criteria;

Exclusion Criteria:

Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified gastroesophageal junction carcinoma;
Patients with known HER2-positive status (patients with unknown HER2 status must be confirmed at the local hospital) are excluded;
Patients with distant metastases other than primary gastric cancer (any M1 stage);
Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
Patients who can not undergo radical surgical resection (D2 radical resection);
Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy);
Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies;
When virological testing prior to screening showed any of the following:
1. patients with active hepatitis (HBV DNA≥1*103 copies or ≥200IU/mL);
2. Anti - HCV positive;
3. HIV positive;
Patients or their families refused to sign this informed consent form to participate in the study.

Sites / Locations

Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab combined with XELOX

Arm Description

Tirelizumab 200mg, iv.gtt, D1, Q3W; Chemotherapy: Oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W.

Outcomes

Primary Outcome Measures

Major pathological response rate(MPR)

Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time.

Secondary Outcome Measures

Pathological complete response rate(pCR)

Pathological complete response

R0 resection rate

Rate of microscopically margin-negative resection

TRAEs and postoperative complications

Including TRAEs and postoperative complications Complications refer to the occurrence of another or several diseases related to the therapeutic behavior of this disease during the treatment of a certain disease.

Full Information

NCT ID

NCT05507658

First Posted

August 17, 2022

Last Updated

July 14, 2023

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05507658

Brief Title

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma

Official Title

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma: A Single-center, Single-arm, Phase Ⅱ Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 18, 2022 (Actual)

Primary Completion Date

July 18, 2024 (Anticipated)

Study Completion Date

July 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The effective treatment of G/GEJ adenocarcinoma has always been a research hotspot in academia. In recent years, mainstream studies have shown that the treatment mode of G/GEJ adenocarcinoma has changed from single surgery mode in the past, to multi-disciplinary comprehensive treatment mode for now, which is based on surgery. Several studies indicate that for most late-stage G/GEJ adenocarcinoma, the neoadjuvant treatment model can further enhance the survival rates and prognosis of patients, compared with the combination of standard radical resection and postoperative adjuvant chemotherapy. According to The Chinese Society of Clinical Oncology (CSCO): clinical guidelines for the diagnosis and treatment of gastric cancer (Wang et al , 2021), neoadjuvant therapy and adjuvant therapy are recommended for patients with G/GEJ adenocarcinoma. However, there is still a lack of unified standards and norms for precise preoperative staging of gastric cancer, applicable population of neoadjuvant along with adjuvant therapy, and the selection of treatment regimens. Therefore, this project is aimed to carry out a single-arm, open-label, phase II clinical trial to administer tirelizumab plus XELOX for neoadjuvant management of patients diagnosed with resectable gastroesophageal junction or stomach cancer, and further explore the safety and therapeutic effect of chemotherapy together with tirelizumab in the neoadjuvant period of G/GEJ adenocarcinoma, eventually, providing a new option for the neoadjuvant treatment of G/GEJ adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Gastric Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tislelizumab combined with XELOX

Arm Type

Experimental

Arm Description

Tirelizumab 200mg, iv.gtt, D1, Q3W; Chemotherapy: Oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W.

Intervention Type

Drug

Intervention Name(s)

Tislelizumab combined with Oxaliplatin and Capecitabine

Intervention Description

Drugs: Tistelizumab 200mg, iv.gtt, D1, Q3W; Chemotherapy (XELOX) : oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W. Neoadjuvant therapy: Tislelizumab combined with XELOX, Q3W, for 2~3 cycles; D2 radical gastrectomy after neoadjuvant therapy. Adjuvant therapy: From 4 to 8 weeks after surgery, the treatment dose was the same as above; Patients who achieved MPR and non-MPR on pathological evaluation were treated with tirelizumab +XELOX 3~8 cycles; Tumor evaluation performed every 3 cycles; The maximum duration of adjuvant therapy was not more than 8 cycles.

Primary Outcome Measure Information:

Title

Major pathological response rate(MPR)

Description

Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time.

Time Frame

From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years

Secondary Outcome Measure Information:

Title

Pathological complete response rate(pCR)

Description

Pathological complete response

Time Frame

From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Title

R0 resection rate

Description

Rate of microscopically margin-negative resection

Time Frame

From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Title

TRAEs and postoperative complications

Description

Time Frame

Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Voluntarily sign the informed consent; Aged 18-80 (including 18 and 80), both sexes; ECOG score ≤1; Biopsy histologically confirmed adenocarcinoma (including Lauren grade); cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy; Exclusion Criteria: Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified gastroesophageal junction carcinoma; Patients with HER2-positive status are excluded; Patients with distant metastases other than primary gastric cancer (any M1 stage); Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy); Patients who can not undergo radical surgical resection (D2 radical resection); Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy); Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies; When virological testing prior to screening showed any of the following: patients with active hepatitis (HBV DNA≥1*103 copies or ≥200IU/mL); Anti - HCV positive; HIV positive; Patients or their families refused to sign this informed consent form to participate in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gang Ji, doctoral

Phone

+8618153227717

xijingweichang@163.com

Facility Information:

Facility Name

Xijing Hospital of Digestive Diseases

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma

We'll reach out to this number within 24 hrs