Pancreatic CancerPhase 2NCT06991491
Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004)
A Phase 2 study testing GnP in combination with Ivonescimab and SBRT in people with Pancreatic Cancer, run by West China Hospital.
Trial summary
The aim of this study is to explore the efficacy and safety of a new combination regimen of GnP regimen, SBRT and the anti-PD-1/VEGF bis-antibody, Ivonescimab, in patients with recurrent metastatic advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- GnP in combination with Ivonescimab and SBRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Sep 2026
- Phase
- Phase 2
- 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;
- Patients who have not received any prior systemic anti-tumor therapy, or who have undergone prior radical pancreatic cancer surgery and received regular postoperative adjuvant chemotherapy, and who have developed recurrence or metastasis more than 6 months after final adjuvant chemotherapy;
- Aged 18 to 75 years old;
- Eastern Cooperative Oncology Group performance status score (ECOG) ≤ 2;
- According to imaging and surgical evaluation, the liver lesion is unresectable or rhe patient is unable to tolerate surgery, and the primary lesion has no serious complications (perforation, obstruction or hemorrhea that cannot be managed by medical therapy);
- At least one measurable tumor lesion: length and diameter of spiral CT greater than or equal to 10 mm, lymph node short diameter greater than or equal to 15 mm; maximum diameter of conventional CT or physical examination greater than or equal to 20mm;
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- Adequate organ functions as follows:
- Absolute neutrophil count ≥1500/mm3, leukocyte≥4000/mm3, platelet count ≥80,000/mm3, hemoglobin ≥9.0 g/dL; total bilirubin≤2.0 × upper limit of normal (UNL); serum creatinine ≤1.5 × UNL; alanine aminotransferase, aspartate aminotransferase ≤5 × UNL;
- Life expectancy of longer than 3 months;
- No history of autoimmune disease and no current co-morbid autoimmune disease;
- Participate the study voluntarily and sign the informed consent document.
Who cannot join
- Subjects with a known allergy to any of the study medications;
- Subjects with known or suspected CNS metastases, i.e., subjects with signs or symptoms suggestive of the development of CNS metastases, unless CNS metastases have been ruled out by CT or MRI;
- History of other malignancies within 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Anti-tumor therapeutic measures other than the treatment regimen of this study must be used concurrently during the study period, including chemotherapy, targeted therapy, hormone therapy, immunotherapy regimens, radiotherapy, and anti-tumor herbal treatments;
- Prior use or ongoing use of chemotherapy, FAK inhibitor analogs, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;
- Diagnosis of immunodeficiency or undergoing chronic systemic steroid therapy (administration of more than 10 mg of prednisone or equivalent per day) or any other form of immunosuppressive therapy within 7 days prior to administering the first dose of this study;
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- Patients receive live vaccines (including, but not limited to: measles, mumps, rubella, varicella/herpes zoster, yellow fever, rabies, BCG, and typhoid vaccines) within 30 days prior to their first dose of study drug therapy, and the use of virus-killed vaccines such as injectable seasonal influenza vaccine is permitted, but the use of live attenuated vaccines such as intranasal influenza vaccine (e.g., fluoride mist) is not permitted;
- Uncontrollable hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg after treatment);
- significant cardiac disease, including congestive heart failure (NYHA Class III-IV), previous myocardial infarction, or uncontrolled angina within 6 months;
- Arrhythmia requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, with ECG abnormalities confirmed by review and in the judgment of the Investigator requiring clinical intervention or treatment;
- History of a hemorrhagic or thromboembolic event within the last 6 months, e.g., cerebrovascular accident (including transient ischemic attack), pulmonary embolism, spontaneous hemorrhage from a tumor;
- need for surgical intervention within 28 days or within 28 days of anticipated last dose
- Combination of uncontrollable third cavity effusion, such as massive pleural effusion or ascites;
- Previous gastrointestinal perforation or suspected gastrointestinal perforation;
- Combinations of medications that, in the judgment of the investigator, must be used during the trial that may affect the metabolism of the product: e.g., strong CYP 3A4 inhibitors or inducers, primarily metabolized by CYP 3A4, 2C8, 2C9, 2C19, or 2D6, and medications with a low therapeutic index;
- Persons with severe mental disorders;
- Women who may be pregnant, gestating, or breastfeeding;
- Subjects of childbearing age who are unwilling to use contraception during the trial period up to 3 months after the last dose;
- Participation in a clinical trial of another drug or medical device within 4 weeks prior to the trial;
- those who, in the judgment of the investigator, are not suitable for enrollment.
About this study
Official title: Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004): an Open-label, Single-arm, Phase II Trial of First-line Multimodal Therapy With Spatial Tumor Immune Microenvironment Analysis
The aim of this study is to explore the efficacy and safety of a new combination regimen of GnP regimen, SBRT and the anti-PD-1/VEGF bis-antibody, Ivonescimab, in patients with recurrent metastatic advanced pancreatic cancer. The efficacy predictive biomarkers of this combination regimen will be further explored through information such as spatial analysis of the tumor immune microenvironment.
- Conditions
- Pancreatic Cancer
- Being tested
- GnP in combination with Ivonescimab and SBRT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnP in combination with Ivonescimab and SBRTCombination product
Gemcitabine 1000mg/m2, ivgtt,vdays 1 and 8, nab-Paclitaxel 125mg/m2, ivgtt, days 1 and 8 in combination with Ivonescimab 20mg/kg d1, every 21 days. Cycle 2 will be synchronized with primary or metastatic SBRT.
| Study group | Role | What they receive |
|---|---|---|
| GnP + Ivonescimab +SBRT | Experimental | Only one cohort of patients will be included, specifically those with pathologically confirmed metastatic pancreatic cancer and, who have not received any prior systemic anti-tumor therapy (including chemotherapy, radiation, or other investigational treatments) or those who have had prior radical pancreatic surgery for pancreatic cancer and have received regular postoperative adjuvant chemotherapy and have developed recurrence or metastasis more than 6 months after the last adjuvant chemotherapy. Receives: Combination Product: GnP in combination with Ivonescimab and SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month-PFS rate
Proportion of patients with progression-free survival at 6 months.
Measured: Follow up with patients for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Cao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991491
- Sponsor's protocol ID
- 2025(352)
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivonescimab With GnP and SBRT in Patients With Metastatic Pancreatic Cancer (WGOG-PAN 004): an Open-label, Single-arm, Phase II Trial of First-line Multimodal Therapy With Spatial Tumor Immune Microenvironment Analysis
- ClinicalTrials.gov ID
- NCT06991491
- Acronym / sponsor ID
- 2025(352)
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to explore the efficacy and safety of a new combination regimen of GnP regimen, SBRT and the anti-PD-1/VEGF bis-antibody, Ivonescimab, in patients with recurrent metastatic advanced pancreatic cancer. The efficacy predictive biomarkers of this combination regimen will be further explored through information such as spatial analysis of the tumor immune microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GnP + Ivonescimab +SBRT | Experimental | Combination Product: GnP in combination with Ivonescimab and SBRTOnly one cohort of patients will be included, specifically those with pathologically confirmed metastatic pancreatic cancer and, who have not received any prior systemic anti-tumor therapy (including chemotherapy, radiation, or other investigational treatments) or those who have had prior radical pancreatic surgery for pancreatic cancer and have received regular postoperative adjuvant chemotherapy and have developed recurrence or metastasis more than 6 months after the last adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with pathologically confirmed metastatic pancreatic cancer;
- Patients who have not received any prior systemic anti-tumor therapy, or who have undergone prior radical pancreatic cancer surgery and received regular postoperative adjuvant chemotherapy, and who have developed recurrence or metastasis more than 6 months after final adjuvant chemotherapy;
- Aged 18 to 75 years old;
- Eastern Cooperative Oncology Group performance status score (ECOG) ≤ 2;
- According to imaging and surgical evaluation, the liver lesion is unresectable or rhe patient is unable to tolerate surgery, and the primary lesion has no serious complications (perforation, obstruction or hemorrhea that cannot be managed by medical therapy);
Key exclusion criteria (20 listed)
- Subjects with a known allergy to any of the study medications;
- Subjects with known or suspected CNS metastases, i.e., subjects with signs or symptoms suggestive of the development of CNS metastases, unless CNS metastases have been ruled out by CT or MRI;
- History of other malignancies within 5 years (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Anti-tumor therapeutic measures other than the treatment regimen of this study must be used concurrently during the study period, including chemotherapy, targeted therapy, hormone therapy, immunotherapy regimens, radiotherapy, and anti-tumor herbal treatments;
- Prior use or ongoing use of chemotherapy, FAK inhibitor analogs, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnP in combination with Ivonescimab and SBRTGemcitabine 1000mg/m2, ivgtt,vdays 1 and 8, nab-Paclitaxel 125mg/m2, ivgtt, days 1 and 8 in combination with Ivonescimab 20mg/kg d1, every 21 days. Cycle 2 will be synchronized with primary or metastatic SBRT. | Combination product | GnP + Ivonescimab +SBRT |
Primary outcome
6-month-PFS rate
Time frame: Follow up with patients for up to 24 months
Proportion of patients with progression-free survival at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GnP in combination with Ivonescimab and SBRT in people with Pancreatic Cancer, 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 11 inclusion and 20 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 28 May 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month-PFS rate (time frame: Follow up with patients for up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.