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

NCT06435260 | Recruiting Phase 2

• 1 other identifier: ARK-pancreatic-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Surgical conversion rate

  2 to 4 weeks after neoadjuvant therapy

• Tumor regression rate

  One week after surgery

• Objective response rate (ORR)

  through study completion，an average of 3 year

• Disease control rate (DCR)

  through study completion，an average of 3 year

• 3-year Overall survival (OS)

  Three years from enrollment

Study Arms (1)

Hypofractionated radiotherapy+Camrelizumab+chemotherapy

EXPERIMENTAL

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; Radiation: hypofractionated radiotherapy

Interventions

Camrelizumab+chemotherapy DRUG

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.

Hypofractionated radiotherapy+Camrelizumab+chemotherapy

hypofractionated radiotherapy RADIATION

Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),

Hypofractionated radiotherapy+Camrelizumab+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
• The investigators think inappropriate.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Li Peng

  Fourth Hospital of Hebei Medical

  PRINCIPAL INVESTIGATOR

• Fengpeng Wu

  Fourth Hospital of Hebei Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Peng

CONTACT

13933868818; pengli72@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)