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

NCT ID: NCT06435260

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Camrelizumab+chemotherapy

Intervention Type: 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

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: DRUG

hypofractionated radiotherapy

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

Intervention Type: RADIATION

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. 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.

2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;

3. The investigators think inappropriate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Peng

Role: PRINCIPAL_INVESTIGATOR

Fourth Hospital of Hebei Medical

Fengpeng Wu

Role: PRINCIPAL_INVESTIGATOR

Fourth Hospital of Hebei Medical

Locations

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Peng

Role: CONTACT

pengli72@sina.com

13933868818

Facility Contacts

Li Peng

Role: primary

pengli72@sina.com

13933868818

Other Identifiers

ARK-pancreatic-001

Identifier Type: -

Identifier Source: org_study_id