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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Patients who did not meet these inclusion criteria;

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

The investigators think inappropriate.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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),

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Hypofractionated radiotherapy+Camrelizumab+chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

a.R0-resection rate

The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically

Time frame
One week after surgery

Secondary outcomes

1

Surgical conversion rate

Tumors that were otherwise unresectable were transformed into surgically resectable tumors.

Time frame
2 to 4 weeks after neoadjuvant therapy
2

Tumor regression rate

Degree of tumor response to neoadjuvant therapy

Time frame
One week after surgery
3

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).

Time frame
through study completion,an average of 3 year
4

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).

Time frame
through study completion,an average of 3 year

Other outcomes

Sponsors and contacts

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