To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435260
• Other study ID #: ARK-pancreatic-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: May 2024
• Source: Hebei Medical University Fourth Hospital
• Contact: Li Peng
• Phone: 13933868818
• Email: pengli72[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 locally advanced pancreatic cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. Clinical assessment was locally advanced (at least qualified one of the following criteria:?Lymph node metastasis outside the surgical area;?tumor surrounded more than half of the superior mesenteric vein;?tumor was adjacent to or wrapped more than half of the celiac artery;?Superior mesenteric vein or portal vein occlusion is not suitable for revascularization;?Invasion or wrapping of the aorta).

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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:40Gy/5F, PTV=25Gy/5F.

Locations

Country	Name	City	State
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a.R0-resection rate	There was no residual by the microscope	within 3 weeks after surgery
Secondary	Conversion to negative rate	The proportion of tumor markers in turned negative	up to 23 weeks
Secondary	Objective response rate (ORR)	Baseline to measured stable disease	tumor assessment every 6 weeks since the treatment began, up to 24 months
Secondary	Disease control rate (DCR)	Baseline to measured progressive disease	tumor assessment every 6 weeks since the treatment began, up to 24 months
Secondary	3-year Overall survival (OS)	Baseline to measured date of death from any cause	3 years
Secondary	3-year Disease Free Survival (DFS)	DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.	3 years
Secondary	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.	3 years
Secondary	Quality of life	Evaluate the quality of life according to QOL-BREF. The number of participants with quality of life will be recorded at each treatment visit.	1 years after therapy