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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily enrolled in the study and signed an informed consent form

18-75 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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab:1200 mg, iv, d1

  • XELOX

    Drug

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Study armExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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