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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT06435260
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

a.R0-resection rate [ Time Frame: One week after surgery ]

Central Contacts

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