Trial Title:
Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients with Locally Advanced or Metastatic Gallbladder Cancer
NCT ID:
NCT06591650
Condition:
Gallbladder Cancer Unresectable
Conditions: Official terms:
Gallbladder Neoplasms
Paclitaxel
Gemcitabine
Durvalumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
gemcitabine hydrochloride
Description:
800 mg/m^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.
Arm group label:
Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
25 mg/m^2, intravenous (IV) over 60 minutes, Days 1,8, every 21 days.
Arm group label:
Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
100 mg/m^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.
Arm group label:
Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
1500mg, intravenous (IV) over 30 minutes, Days 1, every 21 days.
Arm group label:
Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab
Summary:
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.
Durvalumab is a type of drug called a monoclonal antibody, which selectively blocks PD-L1
binding to PD-1. This anti-PD-L1 treatment works by allowing the immune system to detect
your cancer and reactivates the immune response.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age≥18 years at time of study entry.
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Has histologically or cytologically confirmed unresectable locally advanced or
metastatic gallbladder adenocarcinoma.
4. Has at least 1 measurable disease, as defined by RECIST 1.1, at baseline.
5. Has a life expectancy ≥ 3 months from proposed first dose date.
6. Has received no prior anti-cancer therapy for gallbladder adenocarcinoma.
7. 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 upper limit of normal (ULN).
Subjects requiring biliary decompression, biliary stent, or drainage using
percutaneous trans-hepatic cholangiogram are allowed (patients with a declining
bilirubin status post stent placement are eligible with serum
bilirubin≤2.5×ULN);Aspartate aminotransferase (AST)/alanine aminotransferase
(ALT)≤2.5×ULN;Measured creatinine clearance (CL)>50 mL/min or calculated creatinine
CL> 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by
24-hour urine collection for determination of creatinine clearance.
8. 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 dose of durvalumab
9. 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.
10. 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.
Exclusion Criteria:
1. Diagnosis of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or
carcinoma of Vaters ampulla.
2. Known hypersensitivity to any of the study drugs or any of the study drug
excipients.
3. Patients, who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 therapy.
4. 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 lupus
erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with
polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis,
etc.]).
5. 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 syndrome) stable on hormone
replacement; Patients having any chronic skin condition that does not require
systemic therapy; Patients without active disease in the last 5 years (allowed only
after consultation with the study physician); Patients with celiac disease
controlled by diet alone.
6. Has history of allogenic organ transplantation.
7. Has a history of active primary immunodeficiency.
8. Has uncontrolled intercurrent illness, including but not limited to, ongoing or
active infection; symptomatic congestive heart failure; uncontrolled hypertension;
unstable angina pectoris; cardiac arrhythmia; interstitial lung disease; serious
chronic gastrointestinal conditions associated with diarrhea; or psychiatric
illness/social situations that would limit compliance with study requirements, would
substantially increase risk of incurring adverse events (AEs), or would compromise
the ability of the patient to give written informed consent.
9. 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.
10. 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 risk for recurrence; Adequately
treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
Adequately treated carcinoma in situ without evidence of disease.
11. 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 (presence of hepatitis B
surface antigen [HBsAg] and/or anti-HBcAb with detectable hepatitis B virus [HBV]
DNA ≥10 IU/mL), or hepatitis C. Patients with a past or resolved HBV infection
(defined as the presence of hepatitis B core antibody [anti-HBc] and absence of
HBsAg) are eligible. Patients positive for hepatitis C (hepatitis C virus [HCV])
antibody are eligible only if polymerase chain reaction is negative for HCV
ribonucleic acid (RNA).
12. 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, or local steroid injections
(e.g., intra articular injection); Systemic corticosteroids at physiologic doses not
to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for
hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
13. 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.
14. Participated in another clinical study with an investigational product during the
last 4 weeks from the first dose of this study's treatment.
15. Is concurrently enrolled in another clinical study (patient is eligible if the study
is an observational (non interventional) study or if enrollment is during the
follow-up period of an interventional study.
16. Is unsuitable to participate in the study or is unlikely to comply with study
procedures, restrictions and requirements (per judgment by the investigator).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huashan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200040
Country:
China
Contact:
Last name:
Xiangyu Wang
Phone:
18317086082
Email:
wangxymed@163.com
Contact backup:
Last name:
Shenghao Wang
Phone:
18019491524
Email:
shenghaow@126.com
Contact backup:
Last name:
Lun xiu Qin
Start date:
September 10, 2024
Completion date:
September 15, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06591650
