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New treatment option for Gallbladder Cancer Unresectable
Official title Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer
ClinicalTrials.gov ID: NCT06591650
What this study is testing
What is gemcitabine hydrochloride?
gemcitabine hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gallbladder cancer unresectable.
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 phase II trail will evaluate the efficacy and safety of combining gemcitabine hydrochloride, cisplatin, nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation), with durvalumab in treating patients who have locally advanced or metastatic gallbladder cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- 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 and older
You may be able to join if
- Age≥18 years at time of study entry.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has histologically or cytologically confirmed unresectable locally advanced or metastatic gallbladder adenocarcinoma.
- Has at least 1 measurable disease, as defined by RECIST 1.1, at baseline.
- Has a life expectancy ≥ 3 months from proposed first dose date.
You likely can't join if
- Diagnosis of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or carcinoma of Vaters ampulla.
- Known hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patients, who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 therapy.
- Has an active or previously documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn\'s disease]...
- Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable: Patients with vitiligo or...
- Has history of allogenic organ transplantation.
See the full eligibility criteria
- Age≥18 years at time of study entry.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has histologically or cytologically confirmed unresectable locally advanced or metastatic gallbladder adenocarcinoma.
- Has at least 1 measurable disease, as defined by RECIST 1.1, at baseline.
- Has a life expectancy ≥ 3 months from proposed first dose date.
- Has received no prior anti-cancer therapy for gallbladder adenocarcinoma.
- Has adequate bone marrow, liver and renal functions measured within 14 days prior to administration of study treatment: Absolute neutrophil count≥1.5 x109/L;Platelet count≥100×109/L;Serum bilirubin≤2.5×institutional...
- Women with childbearing potential should complete a pregnancy test with negative result within 28 days of study treatment and be willing to use effective contraceptive methods from screening to 90 days after the last...
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm from screening to 90 days after the last dose of durvalumab.
- Capable of giving written informed consent, prior to any study specific procedures,and ability to comply with the study protocol in the investigator\'s judgment.
- Diagnosis of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or carcinoma of Vaters ampulla.
- Known hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patients, who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 therapy.
- Has an active or previously documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn\'s disease], diverticulitis [diverticulosis is not an excluding factor], systemic...
- Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto...
- Has history of allogenic organ transplantation.
- Has a history of active primary immunodeficiency.
- Has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrhythmia...
- Has a prior history of myocardial infarction, transient ischemic attack, or stroke within the past 3 months prior to the scheduled first dose of study treatment.
- Has a history of another primary malignancy. Patients having the following are still eligible: Malignancy treated with curative intent, no known active disease \>= 5 years before the first dose of IP, and low potential...
- Has active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B...
- Is currently using or previously used immunosuppressive medication within 14 days before the first dose of durvalumab. The following medications are exceptions to this criterion: Intranasal, inhaled, topical steroids...
- Is a female and pregnant or breastfeeding; or is a male or female of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose of durvalumab.
- Participated in another clinical study with an investigational product during the last 4 weeks from the first dose of this study\'s treatment.
- Is concurrently enrolled in another clinical study (patient is eligible if the study is an observational (non treatment) study or if enrollment is during the follow-up period of an treatment study.
- Is unsuitable to participate in the study or is unlikely to comply with study procedures, restrictions and requirements (per judgment by the investigator).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.