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A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer

ConditionPancreatic Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJunjie Hang

About this trial

The purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is:

Phase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and/or phase II clinical recommendations Dose (RP2D).

Phase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients.

Participants will:

Phase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg/d (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.

Phase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);

Age ≥ 18 years old and ≤ 80 years old;

Patients with unresectable/metastatic pancreatic cancer confirmed by histopathology;

Imaging confirmation of tumor progression after previous first-line and second-line standard treatment;

Disqualifiers

Have hypersensitivity reactions to any research drug or its components;

Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);

Long QTc syndrome or QTc interval>480 ms;

Complete left bundle branch block, grade II or III atrioventricular block;

Trial design

Design model

Single group

Treatments tested in this trial

  • Regorafenib combined with Toripalimab and Albumin paclitaxel

    Drug

    Regorafenib combined with Toripalimab and Albumin paclitaxel as the third line treatment for patients with advanced pancreatic cancer

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Research Scheme Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

(PFS)

Progression-Free Survival

Time frame
Dated from the first treatment with study medication to the first documented PD or death owing to any cause, whichever occurred first,assessed up to 60 months.

Secondary outcomes

1

ORR

Objective Response Rate

Time frame
up to 60 months
2

OS

Overall Survival

Time frame
Dated from the date of first treatment with study medication to the date of death owing to any cause or censored on the date of last follow-up,assessed up to 60 months.

Other outcomes

Sponsors and contacts

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

Junjie Hang

Lead sponsor

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Sponsor institution

Qilu Pharmaceutical Group Co., Ltd

Collaborator

Shanghai Junshi Biomedical Technology Co., Ltd

Collaborator

Source ClinicalTrials.gov
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