Pancreatic Cancer
Conditions
Brief 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 Borderline Resectable/locally advanced pancreatic cancer.
Interventions
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.
RADIATIONhypofractionated radiotherapy
Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. The pancreatic tumor is located more than 1cm away from the duodenum； 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a.R0-resection rate | One week after surgery | The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical conversion rate | 2 to 4 weeks after neoadjuvant therapy | Tumors that were otherwise unresectable were transformed into surgically resectable tumors. |
| Tumor regression rate | One week after surgery | Degree of tumor response to neoadjuvant therapy |
| Objective response rate (ORR) | through study completion，an average of 3 year | It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1). |
| Disease control rate (DCR) | through study completion，an average of 3 year | It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR/SD) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1). |
| 3-year Overall survival (OS) | Three years from enrollment | The time between the start of randomization and death from any cause |
| 3-year Event Free Survival (EFS) | Three years from enrollment | The time from randomization until disease progression, treatment discontinuation for any cause, or death. |
| Adverse events | From enrollment to the end of treatment at 8 weeks | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit. |
| Quality of life scores | 1 years after therapy | Evaluate the quality of life according to The World Health Organization quality of life (WHOQOL) -BREF. The minimum value is 1, the maximum value is 5. And higher scores mean a better outcome. The number of participants with quality of life will be recorded at each treatment visit. |
Countries
China
Contacts
CONTACTLi Peng
PRINCIPAL_INVESTIGATORLi Peng
Fourth Hospital of Hebei Medical
PRINCIPAL_INVESTIGATORFengpeng Wu
Fourth Hospital of Hebei Medical
Outcome results
None listed