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New treatment option for Perihilar Cholangiocarcinoma
Official title PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05430698
What this study is testing
What is PD-1antibody plus GEMOX?
PD-1antibody plus GEMOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for perihilar cholangiocarcinoma.
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
- This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0 or 1 point;
- Child-Pugh score A period;
- Perihepatic cholangiocarcinoma with negative margins and positively metastatic lymph nodes confirmed by histopathology. Abdominal positively...
You likely can't join if
- Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;
- 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;
See the full eligibility criteria
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0 or 1 point;
- Child-Pugh score A period;
- Perihepatic cholangiocarcinoma with negative margins and positively metastatic lymph nodes confirmed by histopathology. Abdominal positively metastatic lymph nodes region is not limited. The 16 groups of microscopically...
- Have not received any systemic treatment within 6 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...
- For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.
- Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;
- 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 ≥2 measurements);
- 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.