Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Camrelizumab+chemotherapy, hypofractionated radiotherapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer
Overview
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
- Drug Camrelizumab+chemotherapy
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. - Radiation hypofractionated radiotherapy
Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),
Primary outcome measures
- a.R0-resection rate [Time frame: One week after surgery]
Secondary outcome measures (8)
- Surgical conversion rate [Time frame: 2 to 4 weeks after neoadjuvant therapy]
- Tumor regression rate [Time frame: One week after surgery]
- Objective response rate (ORR) [Time frame: through study completion，an average of 3 year]
- Disease control rate (DCR) [Time frame: through study completion，an average of 3 year]
- 3-year Overall survival (OS) [Time frame: Three years from enrollment]
- 3-year Event Free Survival (EFS) [Time frame: Three years from enrollment]
- Adverse events [Time frame: From enrollment to the end of treatment at 8 weeks]
- Quality of life scores [Time frame: 1 years after therapy]
Eligibility criteria
Inclusion criteria
- Age:18 to 75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Tumor was located in the pancreas;
- Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
- No distant metastasis;
- The pancreatic tumor is located more than 1cm away from the duodenum；
- 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
- Patients who did not meet these inclusion criteria;
- Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
- The investigators think inappropriate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fourth Hospital of Hebei Medical University — Shijiazhuang
Identifiers
NCT: NCT06435260 · ARK-pancreatic-001