Combination treatment for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the safety and efficacy of a combination treatment regimen consisting of Nanoliposomal Irinotecan, Oxaliplatin, Capecitabine, and Cadonilimab for patients with advanced pancreatic ductal adenocarcinoma who have not previously received systemic therapy. The study aims to determine how well this treatment works in managing the disease and improving patient outcomes. Participants will be monitored for measurable disease response based on established criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18, male or female;
2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
3. Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
4. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
6. Has a life expectancy of at least 3 months;
7. Has adequate organ function;
8. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
9. If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

Exclusion Criteria:

1. Untreated active CNS metastasis or leptomeningeal metastasis.
2. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
3. Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
4. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
5. Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
6. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids);
7. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
8. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
9. History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
10. Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
11. Is pregnant or breastfeeding;
12. Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: lin yang
• Email: linyangcicams@126.com
• Phone: 13611267380

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Cadonilimab with chemotherapy for treating advanced triple-negative breast cancer

  This study is testing if combining a new antibody treatment called Cadonilimab with chemotherapy can help people with advanced triple-negative breast cancer feel better compared to standard treatments.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT06367088

• Combination treatment for advanced colorectal cancer

  This study is testing a new combination treatment for people with advanced colorectal cancer to see if it helps them live longer without their cancer getting worse.

  Recruiting Phase 2 Fudan University · Shanghai · NCT06218810

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum

  Aims to see if adding targeted radiotherapy and cadonilimab immunotherapy to standard second-line chemotherapy helps adults with colorectal cancer that’s spread only to the peritoneum.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07815834

• Zoldonrasib plus Daraxonrasib vs Gemcitabine and Nab-Paclitaxel as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This study tests whether two investigational RAS inhibitors together can improve outcomes compared with standard chemotherapy in adults with newly diagnosed metastatic pancreatic cancer carrying the KRAS G12D mutation.

  Recruiting at 6 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 5 other locations · NCT07805954

• Concise coaching to guide decisions for advanced cancer patients considering palliative procedures

  A coaching program delivered by lay providers will test whether it helps adults with advanced cancer make better, patient-aligned decisions about palliative surgeries or similar interventions.

  Recruiting Singapore General Hospital · Singapore · NCT07789093

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.