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Tests treatment safety and results for Unresectable Gallbladder Cancer
Official title A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs
ClinicalTrials.gov ID: NCT06423170
What this study is testing
What is Camrelizumab plus GEMOX?
Camrelizumab plus GEMOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable gallbladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and...
- 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...
- 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;
See the full eligibility 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...
- Female people 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...
- Male people 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
- people who voluntarily enter the study, sign an informed consent form, are compliant and willing to cooperate with follow-up
- 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...
- 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 people or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.