Pancreatic CancerPhase 2NCT06944106
A Study on Ivonescimab Plus Chemotherapy as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer
A Phase 2 study testing AK112 in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable 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?
- AK112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2025to 28 Mar 2027
- 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
- Age ≥ 18 years and ≤ 75 years.
- Histologically or cytologically confirmed pancreatic cancer.
- Borderline resectable disease.
- At least one measurable lesion (according to RECIST v1.1); and tumor diameter ≤ 6 cm, distance from the gastrointestinal mucosa ≥ 0.5 cm with no obvious signs of tumor invasion, and no obvious lymph node metastasis.
- No prior anti-tumor treatment for pancreatic cancer.
- ECOG performance status of 0-1.
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- Life expectancy of ≥3 months.
- Hematologic function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L, white blood cells (WBC) ≥3.0×10⁹/L.
- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; total bilirubin ≤1.5×ULN.
- Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated by Cockroft-Gault formula).
- Subjects with reproductive potential must use at least one medically accepted contraceptive method (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 180 days after the end of study treatment. Female subjects must have a negative serum HCG test before the first dose and must not be breastfeeding.
- Ability to understand the nature of the study, and the patient (or legal representative) voluntarily agrees to participate in the trial and signs the informed consent form.
Who cannot join
- Patients who have had other malignancies within the past 5 years (except for cured in situ cancer and basal cell carcinoma of the skin).
- Undergone major surgery within the past 28 days.
- Previously received immunotherapy drugs (including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc.).
- Presence of distant metastases that are not resectable.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined as persistent signs/symptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and/or other treatments.
- Known active HIV infection (i.e., positive for HIV 1/2 antibodies); untreated active HBV (defined as HBsAg positivity with detectable HBV-DNA ≥10⁴/ml or 2000 IU/ml) and HCV infection (positive HCV antibodies with HCV-RNA levels above the upper limit of normal).
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- Presence of uncontrollable systemic diseases (such as a history of cardiovascular diseases like unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmias, or severe pericardial disease).
- Presence of severe gastrointestinal diseases (including active bleeding, obstruction greater than Grade 1 [CTCAE v5.0], or diarrhea greater than Grade 1 [CTCAE v5.0]).
- Any contraindications to chemotherapy, radiotherapy, or surgery as indicated by laboratory or clinical findings.
- Pregnant or breastfeeding women, and women of childbearing potential who refuse to use appropriate contraception during the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Li Huikai, MD, 18622228639, tjchlhk@126.com
About this study
Official title: A Prospective, Single-arm, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab Combined With Gemcitabine and Nab-paclitaxel (AG) Regimen as Neoadjuvant Treatment for Borderline Resectable Pancreatic Cancer
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer.
Read the detailed description
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer. After signing the informed consent, eligible participants will receive three cycles of Ivonescimab in combination with AG before surgery. Radical surgery will be performed within 4 to 8 weeks after the last treatment. For participants who do not meet the surgical criteria, they may continue to receive three more cycles of the same treatment. If, after six cycles, participants still do not meet the surgical criteria but have stable disease based on imaging, they may continue to receive maintenance therapy with Ivonescimab and gemcitabine/nab-paclitaxel until disease progression, death, or intolerable toxicity. After surgery, the necessity and plan for adjuvant therapy will be determined by the investigator based on the patient's condition. Imaging assessments will be conducted every three months postoperatively until disease recurrence. After recurrence, survival follow-up will be performed every three months.
- Conditions
- Pancreatic Cancer
- Being tested
- AK112
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
All enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with gemcitabine and nab-paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| AK112 arm | Experimental | The patients will receive AK112（PD-1/VEGF bispecific antibody）plus gemcitabine and nab-paclitaxel Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 and R1 resection rates
Defined as proportion of patients who have R0 and R1 resection
Measured: up to 1 year
Secondary outcomes (4)
Adverse Events（AEs）
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: up to 3 years
Major Pathological Response(MPR)
The proportion of patients who achieve significant reduction in tumor burden as assessed by pathological examination after neoadjuvant therapy
Measured: up to 1 year
Event-Free Survival (EFS)
The time from the start of treatment to the occurrence of a predefined event, such as disease progression, relapse, or death from any cause
Measured: up to 2 years
Overall survival (OS)
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start28 Mar 2025
- Primary completion28 Apr 2026 (estimated)
- Study completion28 Mar 2027 (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 Tianjin Medical University Cancer Institute and 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944106
- Sponsor's protocol ID
- EC-2025-0043
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab Combined With Gemcitabine and Nab-paclitaxel (AG) Regimen as Neoadjuvant Treatment for Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06944106
- Acronym / sponsor ID
- EC-2025-0043
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 Apr 2026 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 25 Apr 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.
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer.
Detailed description
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer. After signing the informed consent, eligible participants will receive three cycles of Ivonescimab in combination with AG before surgery. Radical surgery will be performed within 4 to 8 weeks after the last treatment. For participants who do not meet the surgical criteria, they may continue to receive three more cycles of the same treatment. If, after six cycles, participants still do not meet the surgical criteria but have stable disease based on imaging, they may continue to receive maintenance therapy with Ivonescimab and gemcitabine/nab-paclitaxel until disease progression, death, or intolerable toxicity. After surgery, the necessity and plan for adjuvant therapy will be determined by the investigator based on the patient's condition. Imaging assessments will be conducted every three months postoperatively until disease recurrence. After recurrence, survival follow-up will be performed every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK112 arm | Experimental | Drug: AK112The patients will receive AK112（PD-1/VEGF bispecific antibody）plus gemcitabine and nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years and ≤ 75 years.
- Histologically or cytologically confirmed pancreatic cancer.
- Borderline resectable disease.
- At least one measurable lesion (according to RECIST v1.1); and tumor diameter ≤ 6 cm, distance from the gastrointestinal mucosa ≥ 0.5 cm with no obvious signs of tumor invasion, and no obvious lymph node metastasis.
- No prior anti-tumor treatment for pancreatic cancer.
Key exclusion criteria (10 listed)
- Patients who have had other malignancies within the past 5 years (except for cured in situ cancer and basal cell carcinoma of the skin).
- Undergone major surgery within the past 28 days.
- Previously received immunotherapy drugs (including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc.).
- Presence of distant metastases that are not resectable.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined as persistent signs/symptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and/or other treatments.
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 |
|---|---|---|
| AK112All enrolled subjects will receive Ivonescimab（AK112，a PD-1/VEGF bispecific antibody，20mg/kg Q3W) in combination with gemcitabine and nab-paclitaxel | Drug | AK112 arm |
Primary outcome
R0 and R1 resection rates
Time frame: up to 1 year
Defined as proportion of patients who have R0 and R1 resection
4 secondary outcomes
Adverse Events（AEs）
Time frame: up to 3 years
Major Pathological Response(MPR)
Time frame: up to 1 year
Event-Free Survival (EFS)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
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 31 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK112 in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Li Huikai, MD (18622228639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 and R1 resection rates (time frame: up to 1 year). 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 31 May 2025.