A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)

NCT06506292 | Recruiting Phase 2

• 1 other identifier: 202407-GC/GEJC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer/adenocarcinoma of the gastroesophageal junction.

Conditions

Adebrelimab (SHR-1316); XELOX; GC/GEJC

Outcome Measures

Primary Outcomes (1)

• Pathological completeresponse, pCR

  Disappearance of tumor cells from resected specimen

  After surgical excision with follow up of an average of 1 year

Secondary Outcomes (8)

• Major Pathological response, MPR

  After surgical excision with follow up of an average of 1 year

• Objective response rate,ORR

  From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year

• R0 resection rate

  After surgical excision with follow up of an average of 1 year

• Event Free Survival, EFS

  From treatment initiation to progressive disease, discontinuation of the treatment for any reason, or death due to any cause, assessed up to 1 year

• Disease control rate, DCR

  From treatment initiation to progressive disease or EOT due to any cause, assessed up to 1 year

Study Arms (1)

Study arm

EXPERIMENTAL

Neoadjuvant therapy: Adebrelimab: 1200 mg, iv, d1, q3w, 3 cycles of treatment; XELOX regimen: oxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14; q3w, 3 cycles; Surgery within 3-6 weeks of the end of neoadjuvant therapy, with adjuvant therapy starting 4-6 weeks after surgery. Postoperative adjuvant therapy： Adebrelimab: 1200 mg, iv, d1; q3w, 5 cycles of treatment; XELOX regimen: oxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14; q3w, treatment for 5 cycles; Perioperative adebelizumab combined with XELOX chemotherapy for a total of no more than 8 cycles of treatment. Maintenance therapy: Adebrelimab maintenance therapy up to 1 year.

Drug: Adebrelimab; Drug: XELOX

Interventions

Adebrelimab DRUG

Adebrelimab:1200 mg, iv, d1

Study arm

XELOX DRUG

oxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14

Study arm

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily enrolled in the study and signed an informed consent form
• years old, male and female gender are not limited
• Gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction as determined by pathologic histology
• Clinical staging of II-III/T3-4aNxM0 (AJCC 8th edition cTNM staging of gastric cancer)
• Clinically judged to be surgically resectable
• have at least one measurable lesion (according to the requirements of RECISTv1.1, the long diameter of spiral CT scan of this measurable lesion is ≥10mm or the short diameter of enlarged lymph node is ≥15mm)
• No other anti-tumor therapy has been received
• ECOG score:0\~1
• Good function of major organs
• No active hepatitis B virus (HBV) infection
• Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, surgical sterilization or agreement to use an appropriate method of contraception during the study and for 3 months after completion of treatment.

You may not qualify if:

• patients who are pregnant or breastfeeding
• Received prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
• other malignant tumor (except basal or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) within the past 5 years
• Uncontrolled pleural effusion, pericardial effusion or ascites
• Clinically determined to be inoperable or with distal metastasis
• Severe cardiovascular disease, such as symptomatic coronary artery disease, class ≥II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, within 12 months prior to enrollment.
• Complicated upper gastrointestinal tract obstruction/bleeding or digestive dysfunction or malabsorption syndrome
• History of gastrointestinal perforation in the 6 months prior to enrollment
• Severe uncontrolled co-infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment
• Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Grade II or higher cardiac insufficiency according to the New York Heart Association (NYHA) criteria (see Appendix 5) or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) \< 50%; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year prior to the initiation of study treatment; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc\>450ms (men); QTc\>470ms (women) (QTc interval calculated by the Fridericia formula; in case of QTc abnormality, three consecutive measurements can be taken at 2-minute intervals and averaged)
• have an allergic reaction to the drugs used in the study
• Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding topical glucocorticosteroids by nasal, inhalational, or other routes or physiologic doses of systemic glucocorticosteroids (i.e., no more than 10 mg/day of prednisone or equivalent doses of other glucocorticosteroids), or use of hormones for the prevention of contrast allergy
• known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• current concomitant interstitial pneumonitis or interstitial lung disease, or a prior history of interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the determination and management of immune-related pulmonary toxicity such as pulmonary fibrosis, mechanized pneumonitis (e.g., occlusive bronchiectasis), pneumonias, drug-associated pneumonias, idiopathic pneumonias, or active pneumonitis as seen on screening chest computed tomography (CT) maps Evidence of or severely impaired lung function in subjects with a history of radiation pneumonitis in the permitted radiation field, active tuberculosis
• presence of active autoimmune disease or history of autoimmune disease with potential for relapse (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism \[subjects who can be controlled by hormone replacement therapy only are eligible for enrollment\]); subjects with a dermatological condition that does not require systemic treatment such as vitiligo psoriasis, alopecia areata, controlled type I diabetes mellitus treated with insulin or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; asthmatics requiring medical intervention with bronchodilators may not be included

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Interventions

XELOX

Central Study Contacts

Bin Ke, MD

CONTACT

86 + 13622036809; binke@tmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)