Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer
ConditionPancreatic Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Yizhong Pharmaceutical Co., Ltd.
About this trial
This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.
Eligibility criteria
Qualifiers
1) Men or women aged 18 to 75 years old (including the critical value).
2）Metastatic pancreatic cancer confirmed by histology or cytology.
3）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.
4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Disqualifiers
1）Patients who are allergic to the investigational drugs and their analogues, or excipients.
2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.
3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.
4）Patients with tumor liver metastasis exceeding 1/2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA>500 IU/ml or research center detection limit [only when the research center limit is above 500 IU/ml]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA > research center detection limit).
Trial design
Treatments tested in this trial
- paclitaxel polymeric micelles for injection
- Gemcitabine Hydrochloride for Injection
- Paclitaxel for Injection (albumin bound )
- Gemcitabine Hydrochloride for Injection
Treatment groups
416 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov