Previously AG Chemotherapy Treated Pancreatic CancerPhase 2NCT06166589
Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer
A Phase 2 study testing Zimberelimab, Oxaliplatin and S-1 in people with Previously AG Chemotherapy Treated Pancreatic Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a prospective, single arm, phase II clinical study investigating second-line Zimberelimab and SIROX chemotherapy for patient with previously AG chemotherapy treated pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously AG Chemotherapy Treated Pancreatic Cancer
- What is being tested?
- Zimberelimab, Oxaliplatin and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are at least 18 years old when signing the informed consent, both male and female.
- Patients with pancreatic cancer progressing after first-line AG regimen chemotherapy, including patients with advanced pancreatic cancer progressing after first-line AG regimen chemotherapy and patients with recurrence and metastasis after radical pancreatic cancer surgery assisted by AG regimen chemotherapy.
- Having not been previously treated with oxaliplatin, S-1, irinotecan and PD-1/L1 antibody.
- According to the judgment of the attending physician, it is appropriate to receive sepalizumab treatment.
- According to RECIST1.1, Patients must have measurable target lesions examined by CT or MRI.
- ECOG PS score: 0-1.
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- Expected survival time ≥3 months.
- All screening period laboratory tests should be performed as required by the protocol and within 14 days prior to the first dose.
- Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female Patients of reproductive age and male Patients whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug.
- Voluntarily participate in clinical research and sign informed consent.
Who cannot join
- Patients have any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Patients with vitiligo or complete remission of asthma in childhood without any intervention after adulthood can be included;Patients with asthma requiring medical intervention with bronchodilators cannot be included);
- Patients are using immunosuppressants, or systemic, or absorbable topical hormone therapy for immunosuppression purposes (dose > 10mg/day prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment;
- Severe allergic reactions to all drugs and excipients involved in the study;
- Clinical cardiac symptoms or diseases that have not been well controlled, such as: (1) NYHA2 or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Urine routine suggests proteinuria ≥++, or confirmed 24-hour urinary protein ≥1.0g;
- Patients have active infection or unexplained fever >38.5 degrees during screening and before the first dose; 7. The Patients have congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal value; hepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value);
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- The Patients have used other drugs in clinical trials within 4 weeks before the first dose;
- The Patients have suffered from other malignant tumors in the past or at the same time;
- The Patients may receive other systemic anti-tumor treatment during the study period;
- The patients with bone metastasis have received palliative radiotherapy in the area >5% of the bone marrow area within 4 weeks before participating in the study;
- The Patients have been vaccinated less than 4 weeks before the study dose or may be vaccinated during the study period;
- In the judgment of the researchers, the Patients have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors that may affect the safety of the Patients, or the collection of data and samples. In the judgment of the researchers, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, drug abuse, other serious diseases (including mental illness) that need combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of medication.
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
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Wei Sun, MD, PhD, +86 21 31587861, sun.wei5@zs-hospital.sh.cn
Liang Liu, MD, PhD
About this study
Official title: The Efficacy and Safety of Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer: A Prospective, Single Arm, Phase II Clinical Study
This is a prospective, single arm, phase II clinical study investigating second-line Zimberelimab and SIROX chemotherapy for patient with previously AG chemotherapy treated pancreatic cancer.
- Being tested
- Zimberelimab, Oxaliplatin, S-1, Irinotecan
- Keywords
- pancreatic cancer, chemotherapy, PD-1 therapy, second-line treatment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZimberelimabDrug
Zimberelimab, 240mg, day1. Every 3 weeks as a cycle.
OxaliplatinDrug
Oxaliplatin 60mg/m2, day1、day8. Every 3 weeks as a cycle.
S-1Drug
S-1(BSA < 1.2m2, 40 mg/day; BSA = 1.2~1.4 m2, 60 mg/day; BSA = 1.4~1.6 m2, 80 mg/day; BSA > 1.6 m2, 100 mg/day; bid, day1-14). Every 3 weeks as a cycle.
IrinotecanDrug
Irinotecan, 130 mg/m2, day 1, day 8. Every 3 weeks as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Zimberelimab in combination with SIROX chemotherapy | Experimental | Not described Receives: Drug: Zimberelimab; Drug: Oxaliplatin; Drug: S-1; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate based on RECIST v1.1
Measured: one year
Secondary outcomes (4)
adverse events
adverse events evaluation based on NCI-CTCAE 5.0
Measured: two years
DCR
Disease control rate evaluation based on RECIST v1.1
Measured: one year
PFS
Progression free survival time
Measured: two years
OS
overall survival time
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously AG Chemotherapy Treated Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang Liu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166589
- Sponsor's protocol ID
- ZSPAC-04
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer: A Prospective, Single Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06166589
- Acronym / sponsor ID
- ZSPAC-04
- Keywords
- pancreatic cancer, chemotherapy, PD-1 therapy, second-line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Dec 2023 (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, single arm, phase II clinical study investigating second-line Zimberelimab and SIROX chemotherapy for patient with previously AG chemotherapy treated 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 |
|---|---|---|
| Zimberelimab in combination with SIROX chemotherapy | Experimental | Drug: Zimberelimab, Drug: Oxaliplatin, Drug: S-1, Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients are at least 18 years old when signing the informed consent, both male and female.
- Patients with pancreatic cancer progressing after first-line AG regimen chemotherapy, including patients with advanced pancreatic cancer progressing after first-line AG regimen chemotherapy and patients with recurrence and metastasis after radical pancreatic cancer surgery assisted by AG regimen chemotherapy.
- Having not been previously treated with oxaliplatin, S-1, irinotecan and PD-1/L1 antibody.
- According to the judgment of the attending physician, it is appropriate to receive sepalizumab treatment.
- According to RECIST1.1, Patients must have measurable target lesions examined by CT or MRI.
Key exclusion criteria (12 listed)
- Patients have any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Patients with vitiligo or complete remission of asthma in childhood without any intervention after adulthood can be included;Patients with asthma requiring medical intervention with bronchodilators cannot be included);
- Patients are using immunosuppressants, or systemic, or absorbable topical hormone therapy for immunosuppression purposes (dose > 10mg/day prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment;
- Severe allergic reactions to all drugs and excipients involved in the study;
- Clinical cardiac symptoms or diseases that have not been well controlled, such as: (1) NYHA2 or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Urine routine suggests proteinuria ≥++, or confirmed 24-hour urinary protein ≥1.0g;
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 |
|---|---|---|
| ZimberelimabZimberelimab, 240mg, day1. Every 3 weeks as a cycle. | Drug | Zimberelimab in combination with SIROX chemotherapy |
| OxaliplatinOxaliplatin 60mg/m2, day1、day8. Every 3 weeks as a cycle. | Drug | Zimberelimab in combination with SIROX chemotherapy |
| S-1S-1(BSA < 1.2m2, 40 mg/day; BSA = 1.2~1.4 m2, 60 mg/day; BSA = 1.4~1.6 m2, 80 mg/day; BSA > 1.6 m2, 100 mg/day; bid, day1-14). Every 3 weeks as a cycle. | Drug | Zimberelimab in combination with SIROX chemotherapy |
| IrinotecanIrinotecan, 130 mg/m2, day 1, day 8. Every 3 weeks as a cycle. | Drug | Zimberelimab in combination with SIROX chemotherapy |
Primary outcome
ORR
Time frame: one year
Objective response rate based on RECIST v1.1
4 secondary outcomes
adverse events
Time frame: two years
DCR
Time frame: one year
PFS
Time frame: two years
OS
Time frame: three 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 12 Dec 2023.
- Individual participant dataSharing planned: No. IPD will not be shared.
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.
Liang Liu, MD, PhD principal investigator
Fudan University
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 Zimberelimab, Oxaliplatin and S-1 in people with Previously AG Chemotherapy Treated Pancreatic Cancer, run by Shanghai Zhongshan 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 10 inclusion and 12 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 12 Dec 2023. 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 Wen-Quan Wang, MD, PhD (021-31587861, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: one 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 12 Dec 2023.