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Search / Trial NCT06202014

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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jan 2, 2024

Trial Information

Current as of July 05, 2025

Recruiting

Keywords

Pancreatic Cancer Envafolimab Capecitabine Radiotherapy

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with locally advanced pancreatic cancer, which is a type of cancer that cannot be surgically removed. The study is testing how well a combination of radiation therapy, a medication called envafolimab, and a chemotherapy drug called capecitabine work together to shrink tumors and improve patient outcomes. Patients who join this trial will receive focused radiation therapy to treat their cancer, along with the two medications, and will be monitored closely to assess the treatment's safety and effectiveness.

To be eligible for this trial, patients must be between 18 and 90 years old and have a confirmed diagnosis of pancreatic cancer that has not spread widely to other parts of the body. They should also have at least one measurable tumor and be in generally good health, meaning their major organs function normally. Participants can expect regular check-ups and tests throughout the study to ensure their safety and track their progress. It's important to note that certain health conditions and medications may exclude some patients from participating, so anyone interested should discuss their situation with their doctor.

Gender

ALL

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.

About Cancer Institute And Hospital, Chinese Academy Of Medical Sciences

The Cancer Institute and Hospital of the Chinese Academy of Medical Sciences is a leading research and treatment center dedicated to advancing cancer care through innovative clinical trials and comprehensive patient services. As a prominent institution in oncology, it focuses on integrating cutting-edge research with clinical practice, fostering collaborations that enhance the understanding and treatment of various cancer types. The institute is committed to improving patient outcomes by exploring novel therapies, optimizing treatment protocols, and contributing to the global fight against cancer through rigorous scientific investigation and evidence-based practices.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported