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RecruitingNCT06506292Updated Jul 17, 2024

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

A Phase 2 interventional study of Adebrelimab and XELOX in Adebrelimab (SHR-1316), XELOX and GC/GEJC, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Gastric cancer is the fifth most common cancer in the world and ranks fourth in mortality. Radical surgery is the main treatment for resectable gastric cancer. For patients with progressive gastric cancer, especially those with stage IIIB and IIIC, their 5-year overall survival (OS) rate after radical surgery is still difficult to exceed 50%. Although D2 radical surgery and postoperative adjuvant chemotherapy have significantly improved the prognosis of patients with progressive gastric cancer, the recurrence rate is still as high as 50%\~80%. Several therapeutic approaches have been established to reduce the risk of recurrence and improve long-term survival, including perioperative chemotherapy, adjuvant chemotherapy, and adjuvant radiotherapy. The effect of adding targeted therapies and/or immune checkpoint inhibitors (ICIs) to neoadjuvant/adjuvant therapies is currently being studied. While multiple programmed death 1 (PD-1) inhibitors have been approved for first/third line treatment of unresectable/metastatic gastric cancer. However, the role of immune checkpoint inhibitors in resectable gastric cancer remains unclear and is being investigated in various clinical trials.

We conducted this study with 8 cycles of perioperative treatment with adebrelimab in combination with XELOX chemotherapy regimen and adebelizumab maintenance therapy up to 1 year. 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.

02

Conditions studied

  • Adebrelimab (SHR-1316)
  • XELOX
  • GC/GEJC
03

In context

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients voluntarily enrolled in the study and signed an informed consent form
  2. 18-75 years old, male and female gender are not limited
  3. Gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction as determined by pathologic histology
  4. Clinical staging of II-III/T3-4aNxM0 (AJCC 8th edition cTNM staging of gastric cancer)
  5. Clinically judged to be surgically resectable
  6. 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)
  7. No other anti-tumor therapy has been received
  8. ECOG score:0\~1
  9. Good function of major organs
  10. No active hepatitis B virus (HBV) infection
  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. patients who are pregnant or breastfeeding
  2. Received prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
  3. other malignant tumor (except basal or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) within the past 5 years
  4. Uncontrolled pleural effusion, pericardial effusion or ascites
  5. Clinically determined to be inoperable or with distal metastasis
  6. Severe cardiovascular disease, such as symptomatic coronary artery disease, class ≥II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, within 12 months prior to enrollment.
  7. Complicated upper gastrointestinal tract obstruction/bleeding or digestive dysfunction or malabsorption syndrome
  8. History of gastrointestinal perforation in the 6 months prior to enrollment
  9. Severe uncontrolled co-infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment
  10. 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)
  11. have an allergic reaction to the drugs used in the study
  12. 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
  13. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
  14. 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
  15. 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
  16. Immunosuppressive or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study treatment (doses >10 mg/day of prednisone or other equipotent hormone)
  17. severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia; therapeutic antibiotics given orally or intravenously within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of COPD are eligible for study participation))
  18. Patients with congenital or acquired immune deficiency (e.g., HIV-infected)
  19. Use of immunosuppressive medications within 4 weeks prior to the first dose of study drug
  20. live attenuated vaccine within 4 weeks prior to the first dose or plan to receive live attenuated vaccine during the study period
  21. previous treatment with other anti-PD-1 antibodies or other immunotherapy against PD-1/PD-L1;
  22. permitted palliative radiotherapy to non-target lesions for symptom control, which must have been completed at least 2 weeks prior to initiation of study treatment use, with no recovery from radiotherapy-induced adverse events to ≤ CTCAE grade 1
  23. received other experimental drug therapy within 28 days prior to initiation of study treatment
  24. In the judgment of the investigator, the patient has other factors that may affect the results of the study or cause this study to be forced to be terminated in midstream, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the patient\'s safety.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Study arm

    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

  • DrugAdebrelimab

    Adebrelimab:1200 mg, iv, d1

  • DrugXELOX

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

06

What researchers measure

Primary outcomes

  1. Pathological completeresponse, pCR

    Disappearance of tumor cells from resected specimen

    Time frame: After surgical excision with follow up of an average of 1 year

Secondary outcomes

  1. Major Pathological response, MPR

    the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of tumor cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% tumor cells.

    Time frame: After surgical excision with follow up of an average of 1 year

  2. Objective response rate,ORR

    Defined as proportion of patients who have a best response of CR or PR

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

  3. R0 resection rate

    Patients who underwent radical resection as a percentage of the total number of patients who underwent surgical resection

    Time frame: After surgical excision with follow up of an average of 1 year

  4. Event Free Survival, EFS

    From date of surgery until the date of recurrence detection.

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

  5. Disease control rate, DCR

    Defined as proportion of patients who have CR or PR or SD

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

  6. Disease-free survival, DFS

    Duration of survival before cancer recurrence or death

    Time frame: From treatment initiation to cancer recurrence or death due to any cause, assessed up to 1 year

  7. Overall Survival, OS

    Defined as the time from enrollment to death from any cause

    Time frame: From treatment initiation until death due to any cause, assessed up to 3 year

  8. AE/SAE

    Incidence of Adverse Events (AE)/Serious Adverse Events (SAE) (as measured by NCI-CTCAE 5.0)

    Time frame: Up to 1 year

07

Study locations

1 of 1 sites recruiting
  • Tianjin Cancer Institute and Hospital
    Tianjin, Tianjin 300052, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06506292
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Jul 17, 2024
Start date
Jul 1, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jul 17, 2024

Study contacts

Bin Ke, MD
Contact
binke@tmu.edu.cn
86 + 13622036809

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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