Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in LAPC

NCT06202014 | Unknown Phase 2

• 1 other identifier: NCC4325
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Radiotherapy; Envafolimab; Capecitabine

Keywords

pancreatic cancer; envafolimab; capecitabine; radiotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  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.

  1-3 months after radiotherapy

Secondary Outcomes (5)

• PFS

  up to 24 months

• OS

  up to 24 months

• DCR

  up to 24 months

• DoR

  up to 24 months

• Incidence of grade 3 and above adverse events

  up to 24 months

Study Arms (1)

Concurrent Radiotherapy With Envafolimab and Capecitabine

EXPERIMENTAL

Concurrent radiotherapy with envafolimab and capecitabine, post-adjuvant envafolimab and capecitabine for locally advanced pancreatic cancer

Radiation: concurrent radiotherapy with envafolimab and capecitabine

Interventions

concurrent radiotherapy with envafolimab and capecitabine RADIATION

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.

Concurrent Radiotherapy With Envafolimab and Capecitabine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Bo Chen

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

envafolimab; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Bo Chen, MD

CONTACT

008613240000876; cbchinese@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: January 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

CN (1)