New cocktail of drugs targets Hard-to-Treat pancreatic cancer
NCT ID NCT07040228
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a combination of three drugs—regorafenib, toripalimab, and albumin-bound paclitaxel—as a third-line treatment for people with advanced pancreatic cancer that has spread or cannot be removed. The study aims to find the safest dose and see if the combo can slow tumor growth. About 23 participants will receive the drugs until their disease worsens or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- regorafenib, toripalimab, and albumin-bound paclitaxel
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced pancreatic cancer who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial with only 23 participants, so results may not apply broadly. The drug combination may cause serious side effects or fail to control the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 23 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF); 2. Age ≥ 18 years old and ≤ 80 years old; 3. Patients with unresectable/metastatic pancreatic cancer confirmed by histopathology; 4. Imaging confirmation of tumor progression after previous first-line and second-line standard treatment; 5. According to RECIST 1.1 criteria, patients must have at least one measurable target lesion; 6. Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points; 7. Expected survival time ≥ 2 months; 8. 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); 9. 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); 10. 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. Exclusion Criteria: 1. Have hypersensitivity reactions to any research drug or its components; 2. Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.); 3. Heart function and disease meet one of the following conditions: 1. Long QTc syndrome or QTc interval\>480 ms; 2. Complete left bundle branch block, grade II or III atrioventricular block; 3. Severe and uncontrolled arrhythmias requiring medication treatment; 4. New York College of Cardiology classification ≥ III; 5. Heart ejection fraction (LVEF) below 50%; 6. 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. 4. 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; 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Imaging confirms intestinal obstruction; 7. 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); 8. Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures; 9. Patients who require treatment for merging with other malignant tumors; 10. History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to the first administration; 11. Within 6 months prior to the first administration, there are arterial embolism, severe bleeding (excluding bleeding caused by surgery), and a tendency for severe bleeding; 12. Merge symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression syndrome; 13. Have used other clinical trial drugs within one month before the first administration; 14. The researchers have determined that patients who are not suitable to participate in this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced pancreatic cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
RECRUITINGShenzhen, Guangdong, 518000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- Personalized drug matching put to the test in pancreatic cancer
- Can engineered immune cells tackle Hard-to-Treat KRAS cancers?
- Can a new injection boost chemotherapy against pancreatic cancer?
- Can a Two-Drug immune attack shrink Hard-to-Treat pancreatic tumors?
- Can three common drugs boost chemotherapy against pancreatic cancer?