Locally Advanced Pancreatic Ductal AdenocarcinomaPhase 2NCT07101679
A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer
A Phase 2 study testing LICSBR in people with Locally Advanced Pancreatic Ductal Adenocarcinoma, run by West China Hospital at 1 site in China.
Trial summary
This study is a single-arm phase II clinical trial. The study targets patients aged 18-75 years with ECOG performance status 0-2, diagnosed with locally advanced pancreatic ductal adenocarcinoma based on comprehensive assessment of pathology and imaging studies (CT or MRI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Ductal Adenocarcinoma
- What is being tested?
- LICSBR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 15 Apr 2029
- 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
- Inclusion Criteria (1)Histologically confirmed pancreatic ductal adenocarcinoma with diagnosis based on comprehensive assessment of pathology and imaging studies (CT or MRI), supplemented by fibroblast activation protein positron emission tomography-computed tomography (FAPI PET-CT) when necessary, determined as locally advanced pancreatic cancer by multidisciplinary team assessment (per 2022 CSCO guideline definition) and deemed unresectable; (2)Treatment-naïve patients with no prior anticancer therapy (including chemotherapy, radiotherapy, surgery, radiofrequency ablation, irreversible electroporation, or other investigational treatments); (3)Age 18-75 years, inclusive, regardless of sex; (4)Eastern Cooperative Oncology Group (ECOG) performance status 0-2; (5)Measurable primary tumor lesions: ≥10 mm in longest diameter on spiral CT, lymph nodes ≥15 mm in short axis diameter; for conventional CT or physical examination, maximum diameter must be ≥20 mm; (6)Adequate major organ function:
- Bone marrow function (no blood transfusion within 14 days prior to screening): White blood cell count (WBC) ≥4.0×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin (Hb) ≥90 g/L;
- Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (for subjects with hepatic metastases: ALT and AST ≤5×ULN, TBIL ≤2×ULN), Child-Pugh score ≤7;
- Renal function: Serum creatinine (Cr) ≤1.5×ULN, proteinuria ≤2+ or ≤2 g/24h, glomerular filtration rate (GFR) ≥60 mL/min/1.73 m²;
- Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) ≤1.5×ULN. Patients receiving stable anticoagulation therapy for at least 30 days prior to study drug treatment may have PT or INR >1.5×ULN if deemed appropriate for the study by investigator assessment, provided adequate justification is documented;
- Serum sodium, potassium, calcium, and magnesium levels ≤Grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0;
- Electrocardiogram showing corrected QT interval (QTc) ≤480 ms; (7)No history of autoimmune disease or current autoimmune disease; (8)Life expectancy ≥3 months; (9)Signed written informed consent prior to any study-related procedures, with ability to understand the protocol and comply with study requirements.
Who cannot join
- Known hypersensitivity or allergy to any of the study drugs;
- Patients with distant metastatic disease classified as Stage IV pancreatic cancer;
- Patients whose tumor lesions are determined by the surgical team or multidisciplinary team to be resectable or borderline resectable pancreatic cancer based on imaging studies (CT or MRI) (per 2022 CSCO guideline definition);
- Patients whose lesions are deemed unsuitable for stereotactic body radiation therapy (SBRT) by investigator assessment;
- Known or suspected central nervous system (CNS) metastases, defined as subjects with signs or symptoms suggestive of CNS metastases, unless CNS metastases have been excluded by CT or MRI;
- History of other malignancies within 5 years (except adequately treated basal cell carcinoma of the skin and cervical carcinoma in situ);
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- Requirement for concurrent anticancer treatments other than the study treatment regimen during the study period, including chemotherapy, targeted therapy, hormonal therapy, immunotherapy regimens, radiotherapy, or traditional Chinese medicine with anticancer properties;
- Prior or current use of chemotherapy, focal adhesion kinase (FAK) inhibitors, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including ipilimumab or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways);
- Diagnosis of immunodeficiency or receiving chronic systemic corticosteroid therapy (daily dose exceeding 10 mg prednisone or equivalent) or any other form of immunosuppressive treatment within 7 days prior to first study drug administration;
- Receipt of live vaccines within 30 days prior to first study drug treatment (including but not limited to: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, bacillus Calmette-Guérin [BCG], and typhoid vaccines). Inactivated vaccines such as injectable seasonal influenza vaccines are permitted, but live attenuated vaccines such as intranasal influenza vaccines (e.g., FluMist) are not allowed;
- Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite treatment);
- Significant cardiac disease, including congestive heart failure (New York Heart Association [NYHA] Class III-IV), prior myocardial infarction, or uncontrolled angina within 6 months;
- Cardiac arrhythmias requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation; confirmed ECG abnormalities deemed by the investigator to require clinical intervention or treatment;
- History of hemorrhagic or thromboembolic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major tumor bleeding;
- Need for surgical treatment within 28 days before or anticipated within 28 days after the last study drug administration;
- Presence of poorly controlled third-space fluid collections, such as large pleural effusions or ascites;
- istory of gastrointestinal perforation or suspected risk of gastrointestinal perforation;
- Investigator determination that concomitant medications required during the study period may affect study drug metabolism, such as strong CYP3A4 inhibitors or inducers, drugs primarily metabolized by CYP3A4, 2C8, 2C9, 2C19, or 2D6 with narrow therapeutic indices;
- Severe psychiatric disorders;
- Pregnancy, potential pregnancy, or lactation;
- Subjects of childbearing potential unwilling to use contraception during the study period and for 3 months after the last study drug administration;
- Participation in other drug or medical device clinical trials within 4 weeks prior to study entry;
- Any condition deemed inappropriate for study participation by investigator judgment.
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
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dan Cao, MD, +8618980605963, caodan@scu.edu.cn
Ke Cheng, MD, 183818128@qq.com
About this study
Official title: A Phase II Clinical Study of GnP Regimen (Nab-paclitaxel + Gemcitabine) Combined With Serplulimab and Stereotactic Body Radiation Therapy (SBRT) as First-line Treatment for Locally Advanced Pancreatic Cancer
This study is a single-arm phase II clinical trial. The study targets patients aged 18-75 years with ECOG performance status 0-2, diagnosed with locally advanced pancreatic ductal adenocarcinoma based on comprehensive assessment of pathology and imaging studies (CT or MRI). Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk [OAR] assessment). Comprehensive evaluation including tumor markers and CT scans will be performed every 2 cycles with multidisciplinary team (MDT) review, and patients who meet surgical criteria will undergo radical resection surgery.
- Being tested
- LICSBR
- Keywords
- SBRT, serplulimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LICSBRDrug
Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk [OAR] assessment).
| Study group | Role | What they receive |
|---|---|---|
| LICSBR GROUP | Experimental | Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk [OAR] assessment). Comprehensive evaluation including tumor markers and CT scans will be performed every 2 cycles with multidisciplinary team (MDT) review, and patients who meet surgical criteria will undergo radical resection surgery.本研究为单臂 II 期临床试验。研究目标为年龄在 18-75 岁之间、ECOG 体能状态评分为 0-2 分、经病理学和影像学综合评估（CT 或 MRI）确诊为局部晚期胰腺导管腺癌的患者。参与患者将接受 GnP 方案治疗，每 21 天一次（第 1 天和第 8 天给予 nab-紫杉醇 125mg/m²静脉滴注，第 1 天和第 8 天给予吉西他滨 1000mg/m²静脉滴注，每 21 天重复一次），联合塞普卢利单抗（ Receives: Drug: LICSBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Objective Response Rate (ORR)
The proportion of subjects in the intention-to-treat (ITT) population who achieve a best overall response of complete response (CR) or partial response (PR) during the study treatment period, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria through radiological imaging (CT/MRI).
Measured: 4 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start16 Apr 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic Ductal AdenocarcinomaStudies 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
- 23 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
- Investigators
- Dan Cao, MD, Principal investigator, Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101679
- Sponsor's protocol ID
- 2025(247)
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy protection requirements, regulatory restrictions in China, and limitations in the original informed consent process that did not include provisions for external data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of GnP Regimen (Nab-paclitaxel + Gemcitabine) Combined With Serplulimab and Stereotactic Body Radiation Therapy (SBRT) as First-line Treatment for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07101679
- Acronym / sponsor ID
- 2025(247)
- Keywords
- SBRT, serplulimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 3 Aug 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 study is a single-arm phase II clinical trial. The study targets patients aged 18-75 years with ECOG performance status 0-2, diagnosed with locally advanced pancreatic ductal adenocarcinoma based on comprehensive assessment of pathology and imaging studies (CT or MRI). Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk [OAR] assessment). Comprehensive evaluation including tumor markers and CT scans will be performed every 2 cycles with multidisciplinary team (MDT) review, and patients who meet surgical criteria will undergo radical resection surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LICSBR GROUP | Experimental | Drug: LICSBRParticipating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk [OAR] assessment). Comprehensive evaluation including tumor markers and CT scans will be performed every 2 cycles with multidisciplinary team (MDT) review, and patients who meet surgical criteria will undergo radical resection surgery.本研究为单臂 II 期临床试验。研究目标为年龄在 18-75 岁之间、ECOG 体能状态评分为 0-2 分、经病理学和影像学综合评估（CT 或 MRI）确诊为局部晚期胰腺导管腺癌的患者。参与患者将接受 GnP 方案治疗，每 21 天一次（第 1 天和第 8 天给予 nab-紫杉醇 125mg/m²静脉滴注，第 1 天和第 8 天给予吉西他滨 1000mg/m²静脉滴注，每 21 天重复一次），联合塞普卢利单抗（ |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion Criteria (1)Histologically confirmed pancreatic ductal adenocarcinoma with diagnosis based on comprehensive assessment of pathology and imaging studies (CT or MRI), supplemented by fibroblast activation protein positron emission tomography-computed tomography (FAPI PET-CT) when necessary, determined as locally advanced pancreatic cancer by multidisciplinary team assessment (per 2022 CSCO guideline definition) and deemed unresectable; (2)Treatment-naïve patients with no prior anticancer therapy (including chemotherapy, radiotherapy, surgery, radiofrequency ablation, irreversible electroporation, or other investigational treatments); (3)Age 18-75 years, inclusive, regardless of sex; (4)Eastern Cooperative Oncology Group (ECOG) performance status 0-2; (5)Measurable primary tumor lesions: ≥10 mm in longest diameter on spiral CT, lymph nodes ≥15 mm in short axis diameter; for conventional CT or physical examination, maximum diameter must be ≥20 mm; (6)Adequate major organ function:
Key exclusion criteria (23 listed)
- Known hypersensitivity or allergy to any of the study drugs;
- Patients with distant metastatic disease classified as Stage IV pancreatic cancer;
- Patients whose tumor lesions are determined by the surgical team or multidisciplinary team to be resectable or borderline resectable pancreatic cancer based on imaging studies (CT or MRI) (per 2022 CSCO guideline definition);
- Patients whose lesions are deemed unsuitable for stereotactic body radiation therapy (SBRT) by investigator assessment;
- Known or suspected central nervous system (CNS) metastases, defined as subjects with signs or symptoms suggestive of CNS metastases, unless CNS metastases have been excluded by CT or MRI;
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 |
|---|---|---|
| LICSBRParticipating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk [OAR] assessment). | Drug | LICSBR GROUP |
Primary outcome
Investigator-assessed Objective Response Rate (ORR)
Time frame: 4 YEARS
The proportion of subjects in the intention-to-treat (ITT) population who achieve a best overall response of complete response (CR) or partial response (PR) during the study treatment period, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria through radiological imaging (CT/MRI).
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 7 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy protection requirements, regulatory restrictions in China, and limitations in the original informed consent process that did not include provisions for external data sharing.
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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.
Dan Cao, MD principal investigator
Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
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 LICSBR in people with Locally Advanced Pancreatic Ductal Adenocarcinoma, run by West China 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 7 inclusion and 23 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 7 Aug 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 Dan Cao, MD (+8618980605963, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed Objective Response Rate (ORR) (time frame: 4 YEARS). 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 7 Aug 2025.