Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Camrelizumab+chemotherapy; Radiation: hypofractionated radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li Peng; Phone Number: 13933868818; Email: pengli72@sina.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • Fourth Hospital of Hebei Medical University
      • Contact: Li Peng; Phone Number: 13933868818; Email: pengli72@sina.com
      • Principal Investigator: Li Peng
      • Principal Investigator: Fengpeng Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hypofractionated radiotherapy+Camrelizumab+chemotherapy; The patients with Borderline Resectable/locally advanced pancreatic cancer were treated with hypofractionated radiotherapy using the CyberKnife radiotherapy machine, which was as follows: PGTV=30Gy/5F(PTV≥25Gy/5F), 1 day, a total of 5 days; Chemotherapy combined with ICIs was started 5-7 days after the end of radiotherapy. The chemotherapy regimen was AG regimen (albumin paclitaxel 125mg/m2 d1,8 + gemcitabine 1000mg/m2 d1,8 q3w). The ICIs regimen consisted of 4 cycles of camrelizumab 200mg q21d (on the first day of each cycle). The efficacy was evaluated within 2 weeks after the end of the above-mentioned neoadjuvant therapy, and surgical treatment was performed for patients who were evaluated as operable and those who had a clear willingness to undergo surgery. After surgery, adjuvant chemotherapy and ICIs of the original scheme were determined according to the patient's tolerance and independent willingness, and then the clinical follow-up period was entered.

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),

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a.R0-resection rate	The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically	One week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical conversion rate	Tumors that were otherwise unresectable were transformed into surgically resectable tumors.	2 to 4 weeks after neoadjuvant therapy
Tumor regression rate	Degree of tumor response to neoadjuvant therapy	One week after surgery
Objective response rate (ORR)	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).	through study completion，an average of 3 year
Disease control rate (DCR)	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).	through study completion，an average of 3 year
3-year Overall survival (OS)	The time between the start of randomization and death from any cause	Three years from enrollment
3-year Event Free Survival (EFS)	The time from randomization until disease progression, treatment discontinuation for any cause, or death.	Three years from enrollment
Adverse events	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.	From enrollment to the end of treatment at 8 weeks
Quality of life scores	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.	1 years after therapy

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Investigators: Principal Investigator: Li Peng, Fourth Hospital of Hebei Medical; Principal Investigator: Fengpeng Wu, Fourth Hospital of Hebei Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: ARK-pancreatic-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No