A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

ConditionPDAC - Pancreatic Ductal Adenocarcinoma

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorWest China Hospital

About this trial

This Phase III randomized trial, evaluates whether adding targeted radiation (SBRT) and an immunotherapy drug (Serplulimab) to standard chemotherapy (GnP) can extend the lives of patients with advanced pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with pathologically confirmed metastatic pancreatic cancer who are inoperable, with diagnosis based on a comprehensive assessment of pathology and imaging studies (CT or MRI);

Patients who have not previously received any systemic anticancer therapy (including chemotherapy, radiotherapy, or other investigational treatments), or who underwent radical pancreatic cancer resection with standard neoadjuvant or adjuvant chemotherapy and experienced recurrence or progression more than 6 months after the last adjuvant chemotherapy;

Age 18-75 years, no gender restriction;

ECOG performance status 0-2;

Disqualifiers

Known allergy to any investigational drug;

Subjects with known or suspected central nervous system (CNS) metastases, i.e., those exhibiting signs or symptoms suggestive of CNS metastases, unless CNS metastases have been ruled out by CT or MRI;

History of other malignancies within 5 years prior to first administration of the study drug (excluding adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ);

Prior treatment with any immune checkpoint inhibitor (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

GnP
Drug
The GnP regimen is a standard-of-care chemotherapy consisting of Gemcitabine and nab-Paclitaxel administered in 21-day cycles.
SBRT
Radiation
Stereotactic Body Radiotherapy (SBRT) is utilized in the experimental arm as a high-dose local treatment intended to induce immunogenic cell death and synergize with immunotherapy.
Serplulimab
Drug
Serplulimab is an immunotherapy component used in the experimental arm of this study to enhance the anti-tumor immune response.

Treatment groups

198 Participants

are divided into 2 treatment groups

Group A: GnP+Serplulimab+SBRTExperimental treatment 3 interventions

Group B: GnPActive comparator 1 intervention

Trial outcomes

Primary outcomes

Overall Survival (OS)

Time frame

From the date of randomization until the date of death from any cause, assessed up to approximately 30 months.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: