A Clinical Study of a Preoperative Translational Therapy for Unresectable Gallbladder Cancer

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with unresectable gallbladder cancer, which means the cancer cannot be removed through surgery. The researchers want to see if combining a type of medication called a PD-1 antibody with a chemotherapy regimen known as GEMOX can help shrink tumors before any further treatment. This study is in its early stages (Phase 2) and is designed to assess both the effectiveness and safety of this combination therapy.

To participate in the trial, patients must be between 18 and 75 years old and have advanced gallbladder cancer that is not suitable for surgery. They should be in relatively good health, as indicated by specific performance and organ function scores. Participants will receive treatment and will be closely monitored for any side effects and how well the therapy works. It's important to note that the trial is not yet recruiting patients, so there is still time to learn more about it before deciding if it's right for you or a loved one.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient must sign an informed consent form;
• • 2. Age 18-75 years old, both male and female;
• • 3. ECOG performance status score (PS score) 0 or 1 point;
• • 4. Child-Pugh score A period;
• • 5. Patients with advanced or recurrent metastatic gallbladder cancer who are not suitable for radical surgery (R0), or non-radical surgery (R1), or palliative surgery, as confirmed by pathological histology or cytology.
• • 6. Have not received any systemic treatment within 6 months;
• • 7. The functional indicators of important organs meet the following requirements (1)Neutrophils≥1.5\*109/L; platelets≥100\*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (calculated by Cockcroft-Gault formula);
• • 8. The subject has at least 1 measurable lesion (according to RECIST1.1);
• • 9. For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.
• Exclusion Criteria:
• • 1. Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
• • 2. Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
• • 3. Severe cardiopulmonary and renal dysfunction;
• • 4. Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
• • 5. Abnormal coagulation function (PT\>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
• • 6. After antiviral treatment, HBV DNA\>2000 copies/ml, HCV RNA\>1000;
• • 7. A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
• • 8. Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;
• • 9. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
• • 10. A history of psychotropic drug abuse, alcohol or drug abuse;
• • 11. Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine;
• • 12. Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.