Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- ORR
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.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.
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.Primary enrollment criteria is locally advanced non-resectable pancreatic cancer without systemic metastases other than retroperitoneal lymph nodes.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.Concurrent and sequential dose of envafolimab is 200mg subcutaneous injection weekly.Capecitabine is with a concurrent and sequential dose of 500-800 mg/m2 bid po , taken orally for 2 weeks and stopped for 1 week (standard concurrent dose is 800 mg/m2 bid po , but for patients ≥70 years of age, 500 mg/m2 bid po depending on physical status ) until progression or intolerance.
Investigators
BO CHEN
Associate Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •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-
- •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
Exclusion Criteria
- •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-L
- •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.
Outcomes
Primary Outcomes
ORR
Time Frame: 1-3 months after radiotherapy
Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after the completion of radiotherapy.
Secondary Outcomes
- Incidence of grade 3 and above adverse events(up to 24 months)
- PFS(up to 24 months)
- DCR(up to 24 months)
- DoR(up to 24 months)
- OS(up to 24 months)