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A single-arm, multicenter, phase II clinical study of gemcitabine combined with paclitaxel (nab-bound) in the treatment of unresectable gallbladder cancer

A single-arm, multicenter, phase II clinical study of gemcitabine combined with paclitaxel (nab-bound) in the treatment of unresectable gallbladder cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055698
Enrollment
Unknown
Registered
2022-01-16
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gallbladder cancer

Interventions

experimental group:AG regimen chemotherapy

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign a written informed consent; 2. Aged 18-75 years, including 18 and 75 years; 3. ECOG score 0-2 points, Child-Pugh grade A; 4. Those diagnosed by histopathology or cytology are not suitable for radical surgery (R0), or undergo non-radical surgery (R1), or undergo palliative surgery, or patients with recurrent and metastatic gallbladder cancer; 5. The functional indicators of vital organs meet the following requirements: (1) Hematological indicators are basically normal: absolute neutrophil count >= 1.5 x 10^9/L; platelet >= 75 x 10^9/L; hemoglobin >= 90 g/L; (2) Renal function is basically normal: serum creatinine = 60 mL/min (3) The liver function is basically normal: serum total bilirubin = 3 months; 7. Non-lactating or pregnant women, contraception during treatment and 3 months after the end.

Exclusion criteria

Exclusion criteria: 1. Severe systemic infection, or other systemic serious uncontrollable diseases (such as heart failure, thyroid disease, mental disease, etc.); 2. Those who are known to be allergic or intolerant to chemotherapy drugs or their excipients; 3. Received anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy) or had any malignant tumor at present or in the past 1 year, except cured cervical carcinoma in situ and non-melanoma skin cancer; 4. Pregnancy or breastfeeding, and childbearing age who refuse to take appropriate contraceptive measures during this trial; 5. Participated in other experimental studies within 30 days before the administration of the first dose of the study drug; 6. Other factors judged by the investigator may affect the subject's safety or test compliance. Such as serious illness (including mental illness) requiring concomitant treatment, serious laboratory test abnormalities, or other family or social factors; 7. Note: When screening, the researcher should ensure that the subjects meet all the inclusion criteria. If the subject's condition changes (including laboratory test results) after screening but before the first dose of study drug is administered and meets the exclusion criteria, the subject should be excluded from the trial.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Countries

China

Contacts

Public ContactWei Gong

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

13651819806@163.com+86 13651683182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026