A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs

Official title

Camrelizumab Plus Gemcitabine and Oxaliplatin (GEMOX) in Patients for Unresectable Gallbladder Cancer: a Single-arm, Phase II Trial

Overview

The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day cycles for 6-8 cycles, with serum tumour markers assessed at each course and abdominal CTA performed every two courses, until tumour progression occurs.The primary indicators of this study are radical tumor resection rate; secondary indicators are disease control rate, objective response rate,progression-free survival and overall survival; safety indicators: incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAEv5.0 criteria. 37 patients are expected to be recruited for this study.

Interventions

• Drug Camrelizumab plus GEMOX
  1. Camrelizumab：200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : oxaliplatin 100mg/m2，D1, gemcitabine1000mg/m2，D1，intravenous infusion. 3. Carrilizumab and GEMOX chemotherapy will be intravenous infused atone day. Three weeks is a course of treatment,a total of 6-8 courses.

Primary outcome measures

• radical tumor resection rate [Time frame: 6 months]

Secondary outcome measures (4)

• Disease Control Rate，DCR [Time frame: 6 months]
• Progress Free Survival，PFS [Time frame: 6 months]
• Overall Survival，OS [Time frame: 6 months]
• Objective response rate，ORR [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Patients aged 18-75 years
• Patients with unresectable gallbladder cancer clearly diagnosed by puncture pathology or the presence of tumour cells in the bile
• No history of chemotherapy or immunotherapy
• ECOG score 0-1 within 1 week prior to enrollment
• Expected survival > 3 months
• 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);
• Female subjects of childbearing potential must have had a negative serum pregnancy study within 14 days prior to the start of study treatment and be willing to use a reliable method of contraception during the study and for 60 days after the final administration of study drug
• Male subjects whose partner is a woman of childbearing age should agree to use a reliable method of contraception for the duration of the study and for 120 days after the last dose of study drug
• Subjects who voluntarily enter the study, sign an informed consent form, are compliant and willing to cooperate with follow-up

Exclusion criteria

• Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
• Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
• Severe cardiopulmonary and renal dysfunction;
• 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 ≥2measurements);
• Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
• After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000;
• A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
• 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;
• Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
• A history of psychotropic drug abuse, alcohol or drug abuse;
• Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine;
• 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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06423170 · SYSKY-2022-516

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗