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Trial Title:
To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer
NCT ID:
NCT06435260
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab+chemotherapy
Description:
Chemotherapy combined with ICIs was started 5-7 days after the completion of
radiotherapy:
AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles.
Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.
Arm group label:
Hypofractionated radiotherapy+Camrelizumab+chemotherapy
Intervention type:
Radiation
Intervention name:
hypofractionated radiotherapy
Description:
Hypofractionated radiotherapy: pGTV:40Gy/5F, PTV≥25Gy/5F.
Arm group label:
Hypofractionated radiotherapy+Camrelizumab+chemotherapy
Summary:
The purpose of this study is to assess surgical conversion rate and the immediate and
long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined
with camrelizumab immunotherapy of locally advanced pancreatic cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age:18 to 75 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Tumor was located in the pancreas;
4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell
carcinoma;
5. No distant metastasis;
6. Clinical assessment was locally advanced or critical for resectable.
Locally advanced pancreatic cancer diagnostic criteria: (1) due to tumor invasion,
venous occlusion or involving a wide range of superior mesenteric vein branch of
jejunum, cannot safely - superior mesenteric vein reconstruction. ② (pancreatic
head/uncinate process tumors) tumor contact with superior mesenteric artery or
celiac artery > 180°. Tumor contact with superior mesenteric artery or coeliac trunk
artery > 180°, tumor contact with coeliac trunk artery and invasion of abdominal
aorta.
Critical for resectable pancreatic cancer diagnostic criteria: (1) contact with
portal vein tumor - superior mesenteric vein > 180 °, 180 ° or less or contact
combined intravenous contour irregular or venous thrombosis, but safety is complete
resection and reconstruction; The tumor contacted the inferior vena cava. ②
(pancreatic head/uncinate process tumors) the tumors contacting the common hepatic
artery, but not involving the celiac artery or the origin of the left and right
hepatic arteries, can be completely resected and safely reconstructed; Superior
mesenteric artery tumor contact 180 ° or less; The tumor contacts the aberrant
arteries (such as accessory right hepatic artery, alternative right hepatic artery,
alternative common hepatic artery, etc.). (pancreatic body and tail tumors) tumor
contact with superior mesenteric artery ≤180°; Tumor contact with celiac artery
≤180°;
7. There was no history of immune system diseases, other malignant tumors, myocarditis,
coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid
dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases,
or systemic diseases other than those mentioned above.
Participants were willing to join in this study, good adherence and written informed
consent.
Exclusion Criteria:
1. Patients who did not meet these inclusion criteria;
2. Poor cognitive ability, inability to answer questions, inability to fill out
questionnaires, or mental disorders;
3. The investigators think inappropriate.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Peng
Phone:
13933868818
Email:
pengli72@sina.com
Investigator:
Last name:
Li Peng
Email:
Principal Investigator
Investigator:
Last name:
Fengpeng Wu
Email:
Principal Investigator
Start date:
August 2024
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435260
