Combining CEND-1 with chemotherapy for pancreatic cancer treatment

A Phase II, Randomized, Double-blind, Multi-center, Placebo-Controlled Study of the Efficacy and Safety of CEND-1 in Combination With Chemotherapy as First-Line Therapy in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma

This study is testing whether adding a new treatment called CEND-1 to standard chemotherapy can help people with advanced pancreatic cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06261359 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of CEND-1 when used alongside gemcitabine and nab-paclitaxel as a first-line treatment for patients with locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Participants will be randomly assigned to receive either the combination of CEND-1 and chemotherapy or chemotherapy with a placebo. The study aims to determine if the addition of CEND-1 improves treatment outcomes compared to standard chemotherapy alone. Patients will be monitored for tumor response and safety throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with locally advanced unresectable or metastatic PDAC who have not received prior systemic therapy.

Not a fit: Patients currently undergoing other anticancer treatments or with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced pancreatic cancer.

How similar studies have performed: While there have been studies on chemotherapy combinations for PDAC, the specific use of CEND-1 in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 18\~80 years old, male or female;
* Locally advanced unresectable or metastatic PDAC confirmed by histopathology or cytopathology;
* Patients who have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer;
* Patients with at least one measurable tumor lesion per RECIST v1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Expected survival time ≥ 12 weeks;
* Patients who have adequate organ function;
* Female subjects who are not pregnant or not breastfeeding. A negative pregnancy test for females of childbearing potential within 7 days prior to first dosing. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.
* Subjects participate voluntarily and sign informed consent.

Exclusion Criteria:

* Concurrent use of other anticancer drugs, including chemotherapy, targeted therapy, immunotherapy, or biologics;
* The patients who are known to be allergic to the investigatinal drug or its any excipient;
* Patients with the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention within 6 months before signing the ICF;
* Patients with high risk for gastrointestinal bleeding or abdominal bleeding as assessed by the investigator, such as tumor invasion of the gastro duodenum finger intestines, large blood vessels, etc.;
* Patients with symptomatic CNS metastasis, leptomeningeal metastasis, or spinal cord compression due to metastasis.
* Patients with other active malignant tumors within 3 years before signing the ICF. Patients with cured skin basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid cancer can be enrolled.
* Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis B and C.
* Patients who require systemic antibiotics for ≥7 days within 4 weeks prior to first dose, or unexplained fever \>38.5°C prior during screening or before first dose;
* Patients who participated in any other clinical studies;
* Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; History of definitive neurological or mental disorder, including epilepsy or dementia;
* The patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.

Where this trial is running

Beijing, Beijing Municipality

• Chinese People's Liberation Army (PLA) General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jianming Xu, M.D

Conditions Pancreatic Ductal Adenocarcinoma