Pancreatic Cancer, AdultPhase 2ACPCNCT06584227
Adebrelimab and Chidamide for Pancreatic Cancer
A Phase 2 study testing Adebrelimab and Chidamide Combined with Gemcitabine and S1 in people with Pancreatic Cancer, Adult, run by Liu Xiufeng at 1 site in China.
Trial summary
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Adult
- What is being tested?
- Adebrelimab and Chidamide Combined with Gemcitabine and S1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 10 May 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
- 18 to 75 years old;
- Histologically or cytologically confirmed pancreatic cancer (originating from the ductal epithelium of the pancreas) with clinically documented unresectable locally advanced or metastatic pancreatic cancer (stage III/IV according to the TNM stage of AJCC 8 pancreatic cancer);
- have not previously received systematic antitumor therapy for the current stage of disease, including surgery (except stent placement), radiotherapy, chemotherapy, targeting, immunotherapy or investigational therapy;
- There must be at least one measurable lesion as a target lesion (according to RECIST v1.1 standards);
- ECOG(American Eastern Cancer Collaboration) Physical status score: 0~1;
- Expected survival ≥3 months;
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- The function of major organs is good (no blood components, cell growth factors, whitening drugs, platelet drugs, anemia correction drugs are allowed within 14 days before enrollment);
- Women of childbearing age must have had a blood pregnancy test within 7 days prior to enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial period and for 6 months after the end of treatment. For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the study period and for 3 months after the end of treatment;
- Voluntarily participate in the study and sign the informed consent;
- Good compliance, agreed to cooperate with the survival follow-up.
Who cannot join
- 1) Have received any of the following treatments:
- Previous treatment with ICIs or HDACi;
- Received the last anti-cancer treatment (including surgery, radiotherapy, etc.) within 4 weeks before enrollment;
- Received any other investigational drug/device treatment within 4 weeks prior to enrollment;
- Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 2) Patients known to be allergic to the components of the investigational drug; 3) Patients with known central nervous system metastasis; 4) Severe gastrointestinal dysfunction (bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2); 5) Serious infections (CTC AE\> Grade 2) occurred within 4 weeks prior to enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc., and symptoms and signs of infection within 2 weeks prior to enrollment requiring intravenous antibiotic treatment (except for prophylactic antibiotic use); 6) Occurrence of arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 1 year before enrollment; 7) Have clinical symptoms or heart diseases that are not well controlled, such as: (1)NYHA2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- 8) Malignancies other than pancreatic cancer prior to initial use of the investigational drug, except malignancies with a low risk of metastasis and risk of death (5-year survival \>90%), such as adequately treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma; 9) Co-active hepatitis B (HBV DNA≥2000IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive); 10) People with acquired immune deficiency syndrome (AIDS) or HIV positive, active syphilis infection; 11) A clear history of neurological or psychiatric disorders, including epilepsy or dementia: 12) Those planning to become pregnant, pregnant and lactating women; 13) In the investigator\'s judgment, the subject has other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious medical conditions (including mental illness) requiring combined treatment, serious abnormalities in laboratory test values, family or social factors that may affect the safety of the subject or the collection of trial data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jianping Li, Prof. M.D. contact
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiufeng liu, Prof. M.D., 025-80860114, liuxiufeng@csco.org.cn
Jianping Li, Prof. M.D.
About this study
Official title: A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.
Read the detailed description
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. There are few approved first-line treatment options for metastatic pancreatic cancer. The FOLFIRINOX regimen (Irinotecan combined with Oxaliplatin and 5FU/LV) is recommended as a first-line treatment for patients with good overall performance status (ECOG 0-1), with a median overall survival of approximately 11.1 months. For patients with ECOG 0-2, the combination of Gemcitabine and Albumin-bound Paclitaxel is an option for first-line chemotherapy, with a median survival of 8.5 months. Single-agent Gemcitabine or S-1 is the standard first-line treatment for patients with poor overall performance status, resulting in a median survival of approximately 6 to 9 months. Therefore, for pancreatic cancer patients, the efficacy of existing first-line treatment regimens has reached a bottleneck, highlighting the urgent need to explore new first-line combination therapy options. Immunotherapy has demonstrated significant advantages in solid tumors, however, its application in pancreatic ductal adenocarcinoma (PDAC) has been disappointing to date. Although several promising preclinical studies have been conducted, translating these findings into clinical research remains challenging, likely due to the complex immunosuppressive tumor microenvironment of PDAC. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer, Adult
- Being tested
- Adebrelimab and Chidamide Combined with Gemcitabine and S1
- Keywords
- Adebrelimab, Chidamide, Gemcitabine, S1, First-Line, Locally Advanced or Metastatic Pancreatic Cancer
- Medical subject headings
- Pancreatic cancer, adult, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab and Chidamide Combined with Gemcitabine and S1Drug
Chidamide:20mg,po,biw,(d8、11、15、18); Adebrelimab: 1200mg,d8,q3w; Gemcitabine:800-1000mg/m2,bid,d1、d8,q3w; S1:40mg/50mg,bid,d1-14,q3w.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab and Chidamide Combined with Gemcitabine and S1 | Experimental | Not described Receives: Drug: Adebrelimab and Chidamide Combined with Gemcitabine and S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start10 Sep 2024
- Primary completion10 Jul 2026 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Xiufeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Xiufeng, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584227
- Sponsor's protocol ID
- 2024-IIT-011
- Acronym
- ACPC
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2024
- Last updated
- 8 Dec 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06584227
- Acronym / sponsor ID
- ACPC / 2024-IIT-011
- Conditions
- Pancreatic Cancer, Adult
- Keywords
- Adebrelimab, Chidamide, Gemcitabine, S1, First-Line, Locally Advanced or Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Liu XiufengUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 4 Sep 2024 (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.
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.
Detailed description
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. There are few approved first-line treatment options for metastatic pancreatic cancer. The FOLFIRINOX regimen (Irinotecan combined with Oxaliplatin and 5FU/LV) is recommended as a first-line treatment for patients with good overall performance status (ECOG 0-1), with a median overall survival of approximately 11.1 months. For patients with ECOG 0-2, the combination of Gemcitabine and Albumin-bound Paclitaxel is an option for first-line chemotherapy, with a median survival of 8.5 months. Single-agent Gemcitabine or S-1 is the standard first-line treatment for patients with poor overall performance status, resulting in a median survival of approximately 6 to 9 months. Therefore, for pancreatic cancer patients, the efficacy of existing first-line treatment regimens has reached a bottleneck, highlighting the urgent need to explore new first-line combination therapy options. Immunotherapy has demonstrated significant advantages in solid tumors, however, its application in pancreatic ductal adenocarcinoma (PDAC) has been disappointing to date. Although several promising preclinical studies have been conducted, translating these findings into clinical research remains challenging, likely due to the complex immunosuppressive tumor microenvironment of PDAC. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab and Chidamide Combined with Gemcitabine and S1 | Experimental | Drug: Adebrelimab and Chidamide Combined with Gemcitabine and S1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 to 75 years old;
- Histologically or cytologically confirmed pancreatic cancer (originating from the ductal epithelium of the pancreas) with clinically documented unresectable locally advanced or metastatic pancreatic cancer (stage III/IV according to the TNM stage of AJCC 8 pancreatic cancer);
- have not previously received systematic antitumor therapy for the current stage of disease, including surgery (except stent placement), radiotherapy, chemotherapy, targeting, immunotherapy or investigational therapy;
- There must be at least one measurable lesion as a target lesion (according to RECIST v1.1 standards);
- ECOG(American Eastern Cancer Collaboration) Physical status score: 0~1;
Key exclusion criteria (6 listed)
- Previous treatment with ICIs or HDACi;
- Received the last anti-cancer treatment (including surgery, radiotherapy, etc.) within 4 weeks before enrollment;
- Received any other investigational drug/device treatment within 4 weeks prior to enrollment;
- Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 2) Patients known to be allergic to the components of the investigational drug; 3) Patients with known central nervous system metastasis; 4) Severe gastrointestinal dysfunction (bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2); 5) Serious infections (CTC AE\> Grade 2) occurred within 4 weeks prior to enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc., and symptoms and signs of infection within 2 weeks prior to enrollment requiring intravenous antibiotic treatment (except for prophylactic antibiotic use); 6) Occurrence of arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 1 year before enrollment; 7) Have clinical symptoms or heart diseases that are not well controlled, such as: (1)NYHA2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- 8) Malignancies other than pancreatic cancer prior to initial use of the investigational drug, except malignancies with a low risk of metastasis and risk of death (5-year survival \>90%), such as adequately treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma; 9) Co-active hepatitis B (HBV DNA≥2000IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive); 10) People with acquired immune deficiency syndrome (AIDS) or HIV positive, active syphilis infection; 11) A clear history of neurological or psychiatric disorders, including epilepsy or dementia: 12) Those planning to become pregnant, pregnant and lactating women; 13) In the investigator\'s judgment, the subject has other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious medical conditions (including mental illness) requiring combined treatment, serious abnormalities in laboratory test values, family or social factors that may affect the safety of the subject or the collection of trial data.
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 |
|---|---|---|
| Adebrelimab and Chidamide Combined with Gemcitabine and S1Chidamide:20mg,po,biw,(d8、11、15、18); Adebrelimab: 1200mg,d8,q3w; Gemcitabine:800-1000mg/m2,bid,d1、d8,q3w; S1:40mg/50mg,bid,d1-14,q3w. | Drug | Adebrelimab and Chidamide Combined with Gemcitabine and S1 |
Primary outcome
Progression free survival
Time frame: 24 months
From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 8 Dec 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.
Jianping Li, Prof. M.D. contact
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 Adebrelimab and Chidamide Combined with Gemcitabine and S1 in people with Pancreatic Cancer, Adult, run by Liu Xiufeng 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 10 inclusion and 6 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 8 Dec 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 Xiufeng Liu, Prof. M.D. (800-555-5555, liuxiufeng@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 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 8 Dec 2025.