Concurrent radiotherapy with envafolimab and capecitabine for locally advanced pancreatic cancer

Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer

This study is testing if combining radiotherapy with the drugs envafolimab and capecitabine can help people with locally advanced pancreatic cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: envafolimab, chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06202014 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial aims to evaluate the safety and efficacy of combining concurrent radiotherapy with envafolimab and capecitabine in patients with locally advanced pancreatic cancer. Eligible participants will receive intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) targeting pancreatic lesions and affected lymph nodes, alongside the administration of envafolimab and capecitabine. The treatment regimen includes weekly subcutaneous injections of envafolimab and oral doses of capecitabine, with specific adjustments for older patients. The study focuses on patients who have not undergone prior systemic chemotherapy or have progressed on first-line therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with locally advanced, non-resectable pancreatic cancer and no systemic metastases other than retroperitoneal lymph nodes.

Not a fit: Patients with resectable pancreatic cancer or those who have received prior systemic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes for patients with locally advanced pancreatic cancer by enhancing the efficacy of radiotherapy.

How similar studies have performed: While this approach is innovative, similar studies combining radiotherapy with targeted therapies have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-90 years old.
2. Pancreatic cancer diagnosed by histology or cytology.
3. Locally or regionally advanced non-resectable pancreatic cancer without systemic metastases other than retroperitoneal lymph nodes.
4. Patients who have not received prior systemic chemotherapy or who have progressed on first-line therapy.
5. At least one measurable lesion (≥10 mm long diameter on CT scan for tumor lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria).
6. ECOG score: 0-1.
7. Expected survival ≥ 3 months.
8. Normal function of major organs, meeting the following criteria:
9. Criteria for routine blood tests need to be met (no blood and blood products transfusion within 14 days):

   1. ANC ≥ 1.5×10\^9/L
   2. PLT ≥80×10\^9/L
10. Biochemical tests need to meet the following criteria:

    1. TBIL\<1.5 ULN
    2. ALT and AST \< 2.5ULN and in patients with liver metastases \< 5ULN
    3. Serum Cr ≤ 1.25ULN or endogenous creatinine clearance \> 45 ml/min (Cockcroft-Gault formula) 11).Subjects voluntarily enrolled in this study and signed an informed consent form, were compliant and cooperated with the follow-up.

Exclusion Criteria:

1. Presence of any active autoimmune disease or history of autoimmune disease in the subject.
2. Allergy to study-used medications.
3. Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose \>10mg/day prednisone or other equipotent hormone) and who continue to be on it within 2 weeks prior to enrollment.
4. Class III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound suggesting left ventricular ejection fraction (LVEF) \<50%.
5. Those with abnormal coagulation function (INR\>1.5,APTT\>1.5 ULN) and bleeding tendency.
6. prolonged unhealed wounds or fractures; major surgical procedures or severe traumatic injuries, fractures or ulcers within 4 weeks.
7. Subjects with congenital or acquired immune deficiency (e.g., HIV-infected individuals), or active hepatitis (Hepatitis B reference: HBV DNA test value exceeding the upper limit of normal, Hepatitis C reference: HCV viral titer or RNA test value exceeding the upper limit of normal).
8. Subject has received other prior PD-1 antibody immunotherapy or other immunotherapy targeting PD-1 or PD-L1.
9. Known existing hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.) or events of arterial or venous thrombosis in the last 6 months (up to the first medication use of envafolimab ).
10. Subjects with active infection or unexplained fever \>38.5 degrees Celsius during screening and prior to the first dose.
11. Patients with central nervous system metastases;
12. Subjects who have had a live bacterial vaccine or live attenuated vaccine vaccine within 30 days prior to the first dose of study treatment.
13. Subjects with previous or concurrent other malignant tumors.
14. Women who are pregnant or breastfeeding.
15. Those with a history of psychotropic substance abuse that cannot be abstained from or patients with psychiatric disorders.
16. Patients with concomitant illnesses that, in the judgment of the investigator, seriously jeopardize patient safety or interfere with the patient's ability to complete the study.
17. Those who are not suitable for inclusion in the judgment of the investigator.

Where this trial is running

Beijing, Beijing

• Bo Chen — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Bo Chen, MD

Conditions: Pancreatic Cancer, Radiotherapy, Envafolimab, Capecitabine, pancreatic cancer, envafolimab, capecitabine, radiotherapy