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

NCT07040228 | Recruiting Phase 1 DMC

• 1 other identifier: YW2025-28-1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer Metastatic

Keywords

Efficacy; Safety; Advanced pancreatic cancer; Regorafenib; Toripalimab

Outcome Measures

Primary Outcomes (1)

• (PFS)

  Progression-Free Survival

  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 (2)

• ORR

  up to 60 months

• OS

  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.

Study Arms (1)

Research Scheme Experimental Group

EXPERIMENTAL

Three line treatment of advanced pancreatic cancer with regofinil combined with teripril monoclonal antibody and albumin paclitaxel

Drug: Regorafenib combined with Toripalimab and Albumin paclitaxel

Interventions

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

Research Scheme Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• According to RECIST 1.1 criteria, patients must have at least one measurable target lesion;
• Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;
• Expected survival time ≥ 2 months;
• Absolute neutrophil count (ANC) ≥ 1.5 × 10 \^ 9/L, platelets ≥ 100 × 10 \^ 9/L, and hemoglobin ≥ 90 g/L (No blood transfusion or blood products within 14 days prior to laboratory examination.
• Not treated with granulocyte colony-stimulating factor or other hematopoietic stimulating factors);
• Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver metastases); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver metastasis);
• Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result must be negative, And willing to use appropriate contraception methods during the trial period and 6 months after the last administration of the trial drug.

You may not qualify if:

• 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.);
• Heart function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval\>480 ms;
• Complete left bundle branch block, grade II or III atrioventricular block;
• Severe and uncontrolled arrhythmias requiring medication treatment;
• New York College of Cardiology classification ≥ III;
• Heart ejection fraction (LVEF) below 50%;
• History of myocardial infarction, unstable angina, and severe unstable ventricular arrhythmia within 6 months prior to recruitment or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or there may be electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
• Active infection of hepatitis B and C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; Hepatitis C virus RNA exceeding 1x103 copies/mL).Asymptomatic chronic carriers of hepatitis B or hepatitis C excluded;
• Human immunodeficiency virus (HIV) infection (HIV antibody positive);
• Imaging confirms intestinal obstruction;
• Previously or currently suffering from other malignant tumors simultaneously (Except for non melanoma basal cell carcinoma and breast/cervical carcinoma in situ that have been effectively controlled and other malignant tumors that have been effectively controlled without treatment in the past five years);
• Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures;
• Patients who require treatment for merging with other malignant tumors;

Sponsors & Collaborators

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: lead
• Qilu Pharmaceutical Group Co., Ltd: collaborator
• Shanghai Junshi Biomedical Technology Co., Ltd: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Hang Junjie, doctorate

CONTACT

86+13681709736; katerhjj0000@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 27, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CN (1)