Pancreatic CancerPhase 2NCT07828756
Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer
A Phase 2 study testing Cisplatin, Albumin-bound Paclitaxel (Ⅱ) and Capecitabine in people with Pancreatic Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG). 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?
- Cisplatin, Albumin-bound Paclitaxel (Ⅱ) and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Apr 2030
- 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
- Aged 18 to 75 years old.
- Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or metastatic pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease. Prior neoadjuvant/adjuvant chemotherapy is permitted, provided the interval from completion of prior chemotherapy to study drug administration is more than 6 months. (2) High-risk resectable or borderline resectable pancreatic cancer assessed by a multidisciplinary team.(3) Curative resection (R0 or R1 resection) performed without prior neoadjuvant therapy, and adjuvant treatment can be initiated within 12 weeks postoperatively.
- Presence of at least one measurable lesion per RECIST v1.1 (exclusive to participants in Cohort 3).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated survival time ≥ 3 months.
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L.
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- Adequate liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤5×ULN allowed in patients with liver metastases); total bilirubin ≤ 1.5×ULN.
- Adequate renal function: serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min (calculated by Cockroft-Gault formula).
- Adequate coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to enrollment, be non-lactating, and agree to use effective contraception throughout the study and for 6 months after the last study treatment. Male participants must agree to effective contraception during the study and for 6 months after study completion.
- Able to understand the study information; participant or legal representative voluntarily provides written informed consent.
Who cannot join
- History of other malignant tumors within the past 5 years
- Known hypersensitivity or intolerance to any study drug or excipients.
- Confirmed homozygous or compound heterozygous DPYD variants leading to complete dihydropyrimidine dehydrogenase (DPD) deficiency.
- Presence of any of the following comorbidities: ① Severe or uncontrolled cardiovascular disease: New York Heart Association (NYHA) Class II or higher chronic heart failure, uncontrolled hypertension (systolic BP >150 mmHg and/or diastolic BP >90 mmHg despite stable medication), etc. ② Severe respiratory disorders: asthma requiring inhaled/systemic glucocorticoids, active chronic obstructive pulmonary disease, etc. ③ Confirmed neurological diseases (epilepsy, dementia, etc.) or Grade ≥2 peripheral sensory/motor neuropathy. ④ Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L under stable treatment). ⑤ Severe chronic or active infections requiring ≥1 consecutive week of systemic antibacterial, antifungal or antiviral therapy (including tuberculosis). ⑥ Active HIV infection (HIV antibody positive); untreated active HBV (HBsAg/HBcAg positive with HBV-DNA above institutional upper limit of normal) or active HCV infection (HCV antibody positive with HCV-RNA above institutional upper limit of normal).
- Untreated active brain metastases (including symptomatic brain or leptomeningeal metastases). Participants with brain metastases are eligible only if brain lesions are stable on imaging performed ≥4 weeks prior to first study dose, no new neurological symptoms or baseline symptom relapse, and no systemic steroid administration for ≥14 days before study treatment initiation, with no evidence of new or enlarged metastatic lesions.
- Medical history as follows: ① Major abdominal/thoracic surgery within 28 days prior to first study dose, or planned major surgery during the study period (diagnostic puncture and infusion port implantation excluded). ② Severe cardiovascular/cerebrovascular events (myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to enrollment; clinically silent lacunar infarcts are permitted.
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- History of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment.
- Inability to swallow or untreated malabsorption syndrome.
- Receipt of any investigational product within 1 month prior to enrollment.
- Any other condition judged by the investigator to render the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-cohort Exploratory Study to Evaluate the Efficacy and Safety of Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer
This is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG).
Cohort 2 enrolls 27 patients with borderline-resectable or high-risk resectable pancreatic cancer, who will receive neoadjuvant therapy with the PAXG regimen.
Read more
Cohort 3 enrolls patients with pancreatic cancer who have undergone curative resection, who will receive adjuvant therapy with nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine.
Objectives of Study: To evaluate the efficacy and safety of nab-paclitaxel (Ⅱ)-based regimes for pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Cisplatin, Albumin-bound Paclitaxel (Ⅱ), Capecitabine, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin: 30 mg/m² , d1
Albumin-bound Paclitaxel (Ⅱ)Drug
Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1
Albumin-bound Paclitaxel (Ⅱ)Drug
Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8
CapecitabineDrug
Capecitabine 625 mg/m²，po，bid, d1-14
CapecitabineDrug
Capecitabine 1660 mg/(m² • d), d1-14
GemcitabineDrug
Gemcitabine 800 mg/m², d1
GemcitabineDrug
Gemcitabine 1000 mg/m², d1, d8
| Study group | Role | What they receive |
|---|---|---|
| Chort 1 | Experimental | Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, Treatment will continue until disease progression or intolerable toxicity. Receives: Drug: Cisplatin; Drug: Albumin-bound Paclitaxel (Ⅱ); Drug: Capecitabine; Drug: Gemcitabine |
| Chort 2 | Experimental | Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, with a maximum of 12 treatment cycles. Receives: Drug: Cisplatin; Drug: Albumin-bound Paclitaxel (Ⅱ); Drug: Capecitabine; Drug: Gemcitabine |
| Chort 3 | Experimental | Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q3w, for a total treatment duration of up to 6 months. Receives: Drug: Albumin-bound Paclitaxel (Ⅱ); Drug: Capecitabine; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: Time from subject's first study drug administration to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 5.5 months.
1-Year Event-Free Survival Rate (1y-EFS Rate)
Measured: 12 months after signing informed consent, until first EFS event or loss to follow-up.
Recommended Phase 2 Dose (RP2D)
Measured: After all participants in each dose cohort complete the 21-day DLT observation period.
Disease-Free Survival (DFS)
Measured: From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.
Secondary outcomes (11)
Objective Response Rate (ORR)
Measured: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months.
Maximum Tolerated Dose (MTD)
Measured: After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.
R0 Resection Rate
Measured: After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.
Incidence of Adverse Events
Measured: From the time of informed consent signature through 30 days after last study drug administration.
Disease Control Rate (DCR)
Measured: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months..
Overall Survival (OS)
Measured: Time from subject's first study drug administration to death from any cause, assessed up to 40 months.
Dose-Limiting Toxicity (DLT)
Measured: After all participants in each dose cohort complete the 21-day DLT observation period.
Event-Free Survival (EFS)
Measured: From informed consent signature to first local recurrence, distant metastasis, tumor progression, second malignancy or all-cause death (whichever occurs first), assessed up to 16 months.
Major Pathological Response (MPR) Rate
Measured: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.
Pathological Complete Response (pCR) Rate
Measured: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.
Duration of Response (DOR)
Measured: Time from first documented CR or PR to subsequent disease progression or death from any cause, whichever occurs first, until end-of-follow-up, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Apr 2030 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828756
- Sponsor's protocol ID
- CSPC-XBZ-PC-K03
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-cohort Exploratory Study to Evaluate the Efficacy and Safety of Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07828756
- Acronym / sponsor ID
- CSPC-XBZ-PC-K03
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 18 Sep 2026 (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 is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG).
Cohort 2 enrolls 27 patients with borderline-resectable or high-risk resectable pancreatic cancer, who will receive neoadjuvant therapy with the PAXG regimen.
Cohort 3 enrolls patients with pancreatic cancer who have undergone curative resection, who will receive adjuvant therapy with nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine.
Objectives of Study: To evaluate the efficacy and safety of nab-paclitaxel (Ⅱ)-based regimes for pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chort 1 | Experimental | Drug: Cisplatin, Drug: Albumin-bound Paclitaxel (Ⅱ), Drug: Capecitabine, Drug: GemcitabineCisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, Treatment will continue until disease progression or intolerable toxicity. |
| Chort 2 | Experimental | Drug: Cisplatin, Drug: Albumin-bound Paclitaxel (Ⅱ), Drug: Capecitabine, Drug: GemcitabineCisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, with a maximum of 12 treatment cycles. |
| Chort 3 | Experimental | Drug: Albumin-bound Paclitaxel (Ⅱ), Drug: Capecitabine, Drug: GemcitabineAlbumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q3w, for a total treatment duration of up to 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 to 75 years old.
- Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or metastatic pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease. Prior neoadjuvant/adjuvant chemotherapy is permitted, provided the interval from completion of prior chemotherapy to study drug administration is more than 6 months. (2) High-risk resectable or borderline resectable pancreatic cancer assessed by a multidisciplinary team.(3) Curative resection (R0 or R1 resection) performed without prior neoadjuvant therapy, and adjuvant treatment can be initiated within 12 weeks postoperatively.
- Presence of at least one measurable lesion per RECIST v1.1 (exclusive to participants in Cohort 3).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated survival time ≥ 3 months.
Key exclusion criteria (10 listed)
- History of other malignant tumors within the past 5 years
- Known hypersensitivity or intolerance to any study drug or excipients.
- Confirmed homozygous or compound heterozygous DPYD variants leading to complete dihydropyrimidine dehydrogenase (DPD) deficiency.
- Presence of any of the following comorbidities: ① Severe or uncontrolled cardiovascular disease: New York Heart Association (NYHA) Class II or higher chronic heart failure, uncontrolled hypertension (systolic BP >150 mmHg and/or diastolic BP >90 mmHg despite stable medication), etc. ② Severe respiratory disorders: asthma requiring inhaled/systemic glucocorticoids, active chronic obstructive pulmonary disease, etc. ③ Confirmed neurological diseases (epilepsy, dementia, etc.) or Grade ≥2 peripheral sensory/motor neuropathy. ④ Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L under stable treatment). ⑤ Severe chronic or active infections requiring ≥1 consecutive week of systemic antibacterial, antifungal or antiviral therapy (including tuberculosis). ⑥ Active HIV infection (HIV antibody positive); untreated active HBV (HBsAg/HBcAg positive with HBV-DNA above institutional upper limit of normal) or active HCV infection (HCV antibody positive with HCV-RNA above institutional upper limit of normal).
- Untreated active brain metastases (including symptomatic brain or leptomeningeal metastases). Participants with brain metastases are eligible only if brain lesions are stable on imaging performed ≥4 weeks prior to first study dose, no new neurological symptoms or baseline symptom relapse, and no systemic steroid administration for ≥14 days before study treatment initiation, with no evidence of new or enlarged metastatic lesions.
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 |
|---|---|---|
| CisplatinCisplatin: 30 mg/m² , d1 | Drug | Chort 1, Chort 2 |
| Albumin-bound Paclitaxel (Ⅱ)Albumin-bound Paclitaxel (Ⅱ): 150 mg/m² , d1 | Drug | Chort 1, Chort 2 |
| Albumin-bound Paclitaxel (Ⅱ)Albumin-bound Paclitaxel (Ⅱ): 100/125 mg/m² , d1, d8 | Drug | Chort 3 |
| CapecitabineCapecitabine 625 mg/m²，po，bid, d1-14 | Drug | Chort 1, Chort 2 |
| CapecitabineCapecitabine 1660 mg/(m² • d), d1-14 | Drug | Chort 3 |
| GemcitabineGemcitabine 800 mg/m², d1 | Drug | Chort 1, Chort 2 |
| GemcitabineGemcitabine 1000 mg/m², d1, d8 | Drug | Chort 3 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Time from subject's first study drug administration to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 5.5 months.
1-Year Event-Free Survival Rate (1y-EFS Rate)
Time frame: 12 months after signing informed consent, until first EFS event or loss to follow-up.
Recommended Phase 2 Dose (RP2D)
Time frame: After all participants in each dose cohort complete the 21-day DLT observation period.
Disease-Free Survival (DFS)
Time frame: From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months.
Maximum Tolerated Dose (MTD)
Time frame: After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.
R0 Resection Rate
Time frame: After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.
Incidence of Adverse Events
Time frame: From the time of informed consent signature through 30 days after last study drug administration.
Disease Control Rate (DCR)
Time frame: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months..
Overall Survival (OS)
Time frame: Time from subject's first study drug administration to death from any cause, assessed up to 40 months.
Dose-Limiting Toxicity (DLT)
Time frame: After all participants in each dose cohort complete the 21-day DLT observation period.
Event-Free Survival (EFS)
Time frame: From informed consent signature to first local recurrence, distant metastasis, tumor progression, second malignancy or all-cause death (whichever occurs first), assessed up to 16 months.
Major Pathological Response (MPR) Rate
Time frame: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.
Pathological Complete Response (pCR) Rate
Time frame: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.
Duration of Response (DOR)
Time frame: Time from first documented CR or PR to subsequent disease progression or death from any cause, whichever occurs first, until end-of-follow-up, assessed up to 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 18 Sep 2026.
- Individual participant dataSharing planned: No
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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 Cisplatin, Albumin-bound Paclitaxel (Ⅱ) and Capecitabine 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 11 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 Jihui Hao (022-2340123-3077, 18622221120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Time from subject's first study drug administration to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 5.5 months.). The study lists 4 primary outcomes in all. 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 18 Sep 2026.