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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • paclitaxel polymeric micelles for injection

    Drug

    Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle.

  • Gemcitabine Hydrochloride for Injection

    Drug

    The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.

  • Paclitaxel for Injection (albumin bound )

    Drug

    Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle.

  • Gemcitabine Hydrochloride for Injection

    Drug

    The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for InjectionExperimental treatment 2 interventions
Group B: paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for InjectionActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free-Survival

PFS(Progression-Free-Survival) is the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurs first.

Time frame
Randomization to measured PD or date of death from any cause（up to 36 months)

Secondary outcomes

1

Overall Survival(OS)

The time from randomization to death.

Time frame
Randomization to date of death from any cause（up to 36 months)
2

Objective Response Rate(ORR)

Proportion of subjects who have achieved complete response (CR) or partial response (PR) (RECIST 1.1)

Time frame
Baseline to measured PD（up to 36 months)
3

Disease Control Rate（DCR）

Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)

Time frame
Baseline to measured PD（up to 36 months)
4

Incidence of adverse events

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0".

Time frame
up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Yizhong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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