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PDAC - Pancreatic Ductal AdenocarcinomaPhase 3NCT07336953

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)

A Phase 3 study testing GnP, SBRT and Serplulimab in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by West China Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PDAC - Pancreatic Ductal Adenocarcinoma
What is being tested?
GnP, SBRT and Serplulimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
No sites listed yet
Study dates
Feb 2026to Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • At least one measurable tumor lesion: ≥10 mm in longest diameter on spiral CT, ≥15 mm in shortest diameter for lymph nodes; ≥20 mm in maximum diameter on conventional CT or physical examination;
  • No more than 10 metastatic lesions throughout the body excluding the primary tumor, with the largest metastatic lesion ≤10 cm in diameter; and at least one lesion deemed suitable for radiotherapy based on imaging assessment;
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  • Normal major organ function (bone marrow, hepatic, renal, coagulation, etc.):
  • Bone marrow function (no transfusion within 14 days prior to screening): WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥80×10⁹/L, Hb ≥90g/L;
  • Liver function: ALT and AST ≤3× upper limit of normal (ULN), TBIL ≤1.5×ULN (if liver metastases present, ALT and AST ≤5×ULN, TBIL ≤2×ULN acceptable for liver-metastatic subjects); Child-Pugh score ≤7 points;
  • Renal function: Serum Cr ≤1.5 ULN, proteinuria ≤2+ or ≤2 g/24h, estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (calculated using Cockcroft-Gault formula);
  • Coagulation function: PT, APTT, and INR ≤1.5×ULN. Patients receiving fixed anticoagulant therapy for at least 30 days prior to study drug administration may have PT or INR >1.5×ULN if deemed suitable for the study by the investigator, provided adequate justification is provided;
  • Serum sodium, potassium, calcium, and magnesium levels ≤ Grade 1 (NCI-CTCAE version 5.0);
  • Electrocardiogram (ECG) showing QTc interval ≤ 480 ms;
  • Expected survival ≥3 months;
  • Female subjects of childbearing potential and male subjects with female partners of childbearing potential must use at least one medically acceptable form of contraception (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for at least 6 months after the last dose of chemotherapy or PD-1 inhibitor;
  • Ability to understand the protocol and comply with its requirements prior to any study-related procedures; full comprehension and voluntary participation in the study, with written informed consent provided.

Who cannot join

  • 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.);
  • Requirement for concomitant antitumor therapy outside the study regimen during the study period, including chemotherapy, targeted therapy, hormonal therapy, other immunotherapy regimens, radiotherapy, or antitumor Chinese herbal medicine;
  • Diagnosis of immunodeficiency or ongoing immunosuppressive therapy within 7 days prior to the first study dose;
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  • Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days prior to the first study drug administration; inhaled or topical steroids are permitted in the absence of active autoimmune disease, and adrenal corticosteroid replacement therapy at a dose ≤10 mg/day prednisone equivalent is allowed;
  • Recipients of antitumor vaccines or live vaccines within 4 weeks prior to the first study drug administration;
  • Major surgery within 28 days prior to the first study drug administration, defined as surgery requiring at least 3 weeks of postoperative recovery before study treatment initiation. Tumor needle biopsies or lymph node excision biopsies are permitted;
  • Requirement for concomitant medications during the trial that may affect the metabolism of the study drug;
  • Presence of uncontrollable third-space effusions (e.g., pleural effusion, pericardial effusion, or ascites);
  • Concurrent uncontrolled cardiovascular or cerebrovascular clinical symptoms or diseases, including but not limited to: NYHA Class II or higher heart failure, unstable angina, myocardial infarction or cerebral infarction within the past 6 months, clinically significant supraventricular or ventricular arrhythmias that remain uncontrolled despite clinical intervention;
  • Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite treatment);
  • History of severe hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major bleeding from tumors;
  • Severe infection (CTCAE ≥ Grade 2) within 4 weeks prior to first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, or infection-related complications; baseline chest imaging demonstrating active pulmonary inflammation with clinically relevant symptoms or signs; Symptoms or signs of infection within 2 weeks prior to the first dose of study drug, requiring oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;
  • Known active autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Exceptions include: vitiligo or childhood asthma/allergies that have resolved without intervention in adulthood; autoimmune-mediated hypothyroidism treated with stable doses of thyroid hormone replacement therapy; type 1 diabetes treated with stable doses of insulin. Subjects in stable condition who do not require systemic immunosuppressive therapy (including corticosteroids) are eligible for enrollment;
  • History of immunodeficiency, including HIV antibody positivity, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation;
  • Active pulmonary tuberculosis infection identified by medical history or CT scan, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment;
  • Subjects HBsAg-positive and/or HBcAb-positive with HBV-DNA ≥500 IU/mL or 2500 copies/mL at baseline. For values exceeding this threshold, enrollment is permitted only if subjects first undergo antiviral therapy to achieve normalization for at least 2 weeks and continue antiviral therapy throughout the study period. For subjects requiring prior antiviral therapy or currently receiving it at screening, inclusion requires continued antiviral treatment throughout the study period, even if HBV-DNA meets inclusion criteria. Hepatitis C (HCV antibody positive and HCV-RNA positive);
  • Concomitant medications deemed by the investigator to potentially affect the metabolism of the study drug during the trial period, such as strong CYP3A4 inhibitors or inducers, drugs primarily metabolized via CYP3A4, 2C8, 2C9, 2C19, or 2D6, and drugs with a narrow therapeutic index;
  • Pregnant or lactating women, or female subjects of childbearing potential unwilling to use contraception during the trial and for 3 months after the last dose;
  • Subjects with other factors deemed by the investigator to potentially necessitate forced discontinuation of the study, such as: - Concurrent treatment for other serious illnesses (including psychiatric disorders) - Severely abnormal laboratory values - Family or social factors that may compromise subject safety or data collection - Subjects deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dan Cao contact

medzpei@163.com

medzpei@163.com

About this study

Official title: A Randomized, Controlled, Phase III Study of Gemcitabine and Nab-paclitaxel (GnP) Combined With Stereotactic Body Radiation Therapy (SBRT) and Serplulimab Versus GnP as First-Line Therapy in Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

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.

Being tested
GnP, SBRT, Serplulimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GnPDrug

    The GnP regimen is a standard-of-care chemotherapy consisting of Gemcitabine and nab-Paclitaxel administered in 21-day cycles.

  • SBRTRadiation

    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.

  • SerplulimabDrug

    Serplulimab is an immunotherapy component used in the experimental arm of this study to enhance the anti-tumor immune response.

Study groups in NCT07336953
Study groupRoleWhat they receive
GnP+Serplulimab+SBRTExperimentalNot described
Receives: Drug: GnP; Radiation: SBRT; Drug: Serplulimab
GnPActive comparatorNot described
Receives: Drug: GnP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336953
Sponsor's protocol ID
WGOG-PAN 006/ICSBR-2
Status last verified
Jan 2026
First submitted
4 Jan 2026
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GnP, SBRT and Serplulimab in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by West China Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dan Cao (medzpei@163.com, medzpei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the date of randomization until the date of death from any cause, assessed up to approximately 30 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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