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

Trial ID: NCT06202014

Interventional - Phase 2 - Unknown status

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of concurrent radiotherapy with envafolimab and capecitabine in locally advanced pancreatic cancer.Eligibility patients will receive intensity-modulated radiotherapy(IMRT)or volumetric modulated arc therapy(VMAT) to pancreatic lesions,metastatic lymph nodes and high-risk lymphatic drainage areas,concurrent with and followed by envafolimab and capecitabine.

Conditions

• Pancreatic Cancer
• Radiotherapy
• Envafolimab
• Capecitabine

Interventions

• concurrent radiotherapy with envafolimab and capecitabine

Eligibility

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.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Source: ClinicalTrials.gov

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