Pancreatic AdenocarcinomaPhase 2NCT06789679
Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer
A Phase 2 study testing Gemcitabine, albumin-bound paclitaxel, S-1 and Gemcitabine, albumin-bound paclitaxel in people with Pancreatic Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a prospective, open-label, randomized controlled trial that enrolled previously untreated patients with locally advanced or metastatic pancreatic cancer. Participants were randomly assigned to receive either albumin-bound paclitaxel and gemcitabine, or albumin-bound paclitaxel, gemcitabine, and S-1 as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine, albumin-bound paclitaxel, S-1 and Gemcitabine, albumin-bound paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2025to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant must voluntarily agree to participate in the study and sign the informed consent form.
- The participant must be ≥18 years old on the day of signing the informed consent form.
- The participant must have a pathological diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
- The participant must not have received any prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
- Note: Patients who have received neoadjuvant/adjuvant/radical chemoradiotherapy or neoadjuvant/adjuvant chemotherapy are eligible only if the time from the end of treatment to the first diagnosis of disease progression/recurrence is at least 6 months.
- The participant must have measurable lesions according to RECIST 1.1 criteria. If there is only one measurable lesion at baseline, it must not have been previously irradiated or there must be evidence of significant progression since the end of radiotherapy.
- The participant must have an ECOG performance status score of 0-2. The participant must have a life expectancy of more than 3 months. The participant must be able to take oral chemotherapy. The participant must meet the required organ function criteria before inclusion.
- Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use highly effective contraception starting 7 days before randomization and continue until 24 weeks after treatment initiation. Female participants must have a negative serum pregnancy test within 7 days prior to randomization.
Who cannot join
- Participants with untreated active brain metastases or leptomeningeal metastasis. If brain metastasis has been treated and the disease is stable (with stable imaging for at least 4 weeks prior to randomization and no new neurological symptoms), they may be included.
- Participants with untreated spinal compression fractures. Treated spinal compression fractures must be stable for at least 2 weeks before randomization.
- Participants who have previously received systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
- Note: Participants who have received neoadjuvant/adjuvant/radical chemoradiotherapy or neoadjuvant/adjuvant chemotherapy are excluded if the time from the end of treatment to disease progression/recurrence is less than 6 months.
- Participants with high risk of gastrointestinal or abdominal bleeding. Participants with uncontrolled cancer pain (e.g., requiring escalation of analgesics) at the time of enrollment.
- Participants who have received chemotherapy, small molecule inhibitors, immunotherapy (such as interleukins, interferons, or thymosin), or other anti-cancer treatments within 28 days before enrollment, or who have used traditional Chinese medicine with anti-cancer indications within 14 days before enrollment.
Show all 16Show fewer
- Participants who have had major surgery within 28 days before enrollment (excluding diagnostic biopsies such as EUS-FNB or percutaneous liver biopsy).
- Participants who have received radical radiation therapy within the last 3 months. Palliative radiation therapy is allowed if administered at least 2 weeks prior to the start of the study treatment.
- Participants with a history of another malignancy within the last 5 years, except for treated basal cell carcinoma, squamous cell carcinoma of the skin, non-invasive bladder cancer, or cured prostate/cervical/breast cancer.
- Participants with uncontrolled comorbidities, including but not limited to:
- Active HBV or HCV infection. Note: Participants with positive HBsAg and/or HCV antibodies must undergo HBV-DNA and/or HCV-RNA testing. Eligible participants must have HBV-DNA ≤500 IU/mL (or ≤2000 copies/mL) and/or HCV-RNA negative.
- Known HIV infection or AIDS history. Active syphilis. Active tuberculosis. Active infections. Uncontrolled hypertension, symptomatic heart failure (NYHA II-IV), unstable angina, myocardial infarction within the last 6 months, or QTc prolongation or arrhythmia risk.
- Note: Participants with baseline QTc >470 msec (female) / 450 msec (male), hypokalemia, long QT syndrome, resting heart rate >100 bpm in atrial fibrillation, or severe valvular heart disease are excluded.
- Active bleeding. Participants whose toxicity from prior anti-cancer treatments has not recovered to CTCAE ≤1 (except for alopecia, which is allowed at any grade, and peripheral neuropathy, which must have recovered to ≤2).
- Breastfeeding women. Other conditions that, in the opinion of the investigator, may affect the participant's safety, compliance, or the reliability of the study results, including but not limited to psychiatric disorders, moderate to severe ascites, pleural effusion, pericardial effusion, etc.
- Vulnerable populations, including but not limited to those with cognitive impairments, critically ill patients, minors, pregnant women, students/subordinates of the investigator, employees of the study institution or sponsor, and other individuals who may not be able to provide informed consent or comply with the study requirements.
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
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chaoyang District, 100021
Lin YANG, Doctor
About this study
Official title: Randomized Phase II Clinical Study of Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
This study is a prospective, open-label, randomized controlled trial that enrolled previously untreated patients with locally advanced or metastatic pancreatic cancer. Participants were randomly assigned to receive either albumin-bound paclitaxel and gemcitabine, or albumin-bound paclitaxel, gemcitabine, and S-1 as first-line treatment. After patients who met the inclusion criteria signed an informed consent form, the study observed patients from the start of treatment until death, withdrawal of consent, loss to follow-up, or the end of the study. Eligible participants were randomly assigned in a 1:1 ratio to either the albumin-bound paclitaxel and gemcitabine treatment group (AG ) or the albumin-bound paclitaxel, gemcitabine, and S-1 treatment group (GAS). A total of 128 patients were planned for inclusion in the study, with 64 in each treatment group. Baseline data related to demographics, disease, treatment, adverse events, and tumor status were collected by the treating physician during the first visit and follow-up visits. Follow-up visits were conducted according to a fixed schedule, with survival assessed every three months through phone calls, WeChat, or by contacting other physicians. The final visit recorded patient death, withdrawal of consent, loss to follow-up, or the conclusion of the study.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, albumin-bound paclitaxel, S-1, Gemcitabine, albumin-bound paclitaxel
- Keywords
- Pancreatic adenocarcinoma, Advanced, First-Line, Efficacy, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, albumin-bound paclitaxel, S-1Drug
Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，q2w Gem：1000mg/m2，ivgtt，D1，q2w S-1：40-60mg Bid，PO，d1-7，q2w
Gemcitabine, albumin-bound paclitaxelDrug
Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，D8，q3w Gem：1000mg/m2，ivgtt，D1，D8，q3w
| Study group | Role | What they receive |
|---|---|---|
| AG Group | Active comparator | Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，D8，q3w Gem：1000mg/m2，ivgtt，D1，D8，q3w Receives: Drug: Gemcitabine, albumin-bound paclitaxel |
| GAS Group | Experimental | Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，q2w Gem：1000mg/m2，ivgtt，D1，q2w S-1：40-60mg Bid，PO，D1-7，q2w Receives: Drug: Gemcitabine, albumin-bound paclitaxel, S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 1 year
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: 1 year
Overall Survival (OS)
Measured: 2 years
Progression-free survival(PFS)
Measured: 1 year
Disease Control Rate(DCR)
Measured: 1 year
Duration of Response (DOR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start25 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Lin Yang, Prof, Principal investigator, LIN YA Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789679
- Sponsor's protocol ID
- NCC5036
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Clinical Study of Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06789679
- Acronym / sponsor ID
- NCC5036
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic adenocarcinoma, Advanced, First-Line, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 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 prospective, open-label, randomized controlled trial that enrolled previously untreated patients with locally advanced or metastatic pancreatic cancer. Participants were randomly assigned to receive either albumin-bound paclitaxel and gemcitabine, or albumin-bound paclitaxel, gemcitabine, and S-1 as first-line treatment. After patients who met the inclusion criteria signed an informed consent form, the study observed patients from the start of treatment until death, withdrawal of consent, loss to follow-up, or the end of the study. Eligible participants were randomly assigned in a 1:1 ratio to either the albumin-bound paclitaxel and gemcitabine treatment group (AG ) or the albumin-bound paclitaxel, gemcitabine, and S-1 treatment group (GAS). A total of 128 patients were planned for inclusion in the study, with 64 in each treatment group. Baseline data related to demographics, disease, treatment, adverse events, and tumor status were collected by the treating physician during the first visit and follow-up visits. Follow-up visits were conducted according to a fixed schedule, with survival assessed every three months through phone calls, WeChat, or by contacting other physicians. The final visit recorded patient death, withdrawal of consent, loss to follow-up, or the conclusion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AG Group | Active comparator | Drug: Gemcitabine, albumin-bound paclitaxelAlbumin-bound paclitaxel：125mg/m2，ivgtt，D1，D8，q3w Gem：1000mg/m2，ivgtt，D1，D8，q3w |
| GAS Group | Experimental | Drug: Gemcitabine, albumin-bound paclitaxel, S-1Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，q2w Gem：1000mg/m2，ivgtt，D1，q2w S-1：40-60mg Bid，PO，D1-7，q2w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant must voluntarily agree to participate in the study and sign the informed consent form.
- The participant must be ≥18 years old on the day of signing the informed consent form.
- The participant must have a pathological diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma).
- The participant must not have received any prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
- Note: Patients who have received neoadjuvant/adjuvant/radical chemoradiotherapy or neoadjuvant/adjuvant chemotherapy are eligible only if the time from the end of treatment to the first diagnosis of disease progression/recurrence is at least 6 months.
Key exclusion criteria (16 listed)
- Participants with untreated active brain metastases or leptomeningeal metastasis. If brain metastasis has been treated and the disease is stable (with stable imaging for at least 4 weeks prior to randomization and no new neurological symptoms), they may be included.
- Participants with untreated spinal compression fractures. Treated spinal compression fractures must be stable for at least 2 weeks before randomization.
- Participants who have previously received systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.
- Note: Participants who have received neoadjuvant/adjuvant/radical chemoradiotherapy or neoadjuvant/adjuvant chemotherapy are excluded if the time from the end of treatment to disease progression/recurrence is less than 6 months.
- Participants with high risk of gastrointestinal or abdominal bleeding. Participants with uncontrolled cancer pain (e.g., requiring escalation of analgesics) at the time of enrollment.
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 |
|---|---|---|
| Gemcitabine, albumin-bound paclitaxel, S-1Albumin-bound paclitaxel：125mg/m2，ivgtt，D1，q2w Gem：1000mg/m2，ivgtt，D1，q2w S-1：40-60mg Bid，PO，d1-7，q2w | Drug | GAS Group |
| Gemcitabine, albumin-bound paclitaxelAlbumin-bound paclitaxel：125mg/m2，ivgtt，D1，D8，q3w Gem：1000mg/m2，ivgtt，D1，D8，q3w | Drug | AG Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 year
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 year
Overall Survival (OS)
Time frame: 2 years
Progression-free survival(PFS)
Time frame: 1 year
Disease Control Rate(DCR)
Time frame: 1 year
Duration of Response (DOR)
Time frame: 1 year
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 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Lin Yang, Prof principal investigator
LIN YA Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Gemcitabine, albumin-bound paclitaxel, S-1 and Gemcitabine, albumin-bound paclitaxel in people with Pancreatic Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 inclusion and 16 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 30 Jan 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 Lin Yang, Doctor (13681015148, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 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 30 Jan 2025.