Status:
RECRUITING
Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in LAPC
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Pancreatic Cancer
Radiotherapy
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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.Eligi...
Detailed Description
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.Prima...
Eligibility Criteria
Inclusion
- Age: 18-90 years old.
- Pancreatic cancer diagnosed by histology or cytology.
- Locally or regionally advanced non-resectable pancreatic cancer without systemic metastases other than retroperitoneal lymph nodes.
- Patients who have not received prior systemic chemotherapy or who have progressed on first-line therapy.
- 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).
- ECOG score: 0-1.
- Expected survival ≥ 3 months.
- Normal function of major organs, meeting the following criteria:
- Criteria for routine blood tests need to be met (no blood and blood products transfusion within 14 days):
- ANC ≥ 1.5×10\^9/L
- PLT ≥80×10\^9/L
- Biochemical tests need to meet the following criteria:
- TBIL\<1.5 ULN
- ALT and AST \< 2.5ULN and in patients with liver metastases \< 5ULN
- 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
- Presence of any active autoimmune disease or history of autoimmune disease in the subject.
- Allergy to study-used medications.
- 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.
- Class III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound suggesting left ventricular ejection fraction (LVEF) \<50%.
- Those with abnormal coagulation function (INR\>1.5,APTT\>1.5 ULN) and bleeding tendency.
- prolonged unhealed wounds or fractures; major surgical procedures or severe traumatic injuries, fractures or ulcers within 4 weeks.
- 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).
- Subject has received other prior PD-1 antibody immunotherapy or other immunotherapy targeting PD-1 or PD-L1.
- 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 ).
- Subjects with active infection or unexplained fever \>38.5 degrees Celsius during screening and prior to the first dose.
- Patients with central nervous system metastases;
- Subjects who have had a live bacterial vaccine or live attenuated vaccine vaccine within 30 days prior to the first dose of study treatment.
- Subjects with previous or concurrent other malignant tumors.
- Women who are pregnant or breastfeeding.
- Those with a history of psychotropic substance abuse that cannot be abstained from or patients with psychiatric disorders.
- 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.
- Those who are not suitable for inclusion in the judgment of the investigator.
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06202014
Start Date
January 31 2024
End Date
December 31 2025
Last Update
January 19 2024
Active Locations (1)
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1
Bo Chen
Beijing, Beijing Municipality, China, 100021