Pancreatic CancerPhase 4NCT06779318
Maintenance Chemotherapy With S-1 vs. Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence/Metastasis
A Phase 4 study testing S-1 in people with Pancreatic Cancer and Postoperative Adjuvant Therapy, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this real-world study is to learn if maintenance chemotherapy with Tegafur, Gimeracil, and Oteracil Potassium (S-1) can improve disease-free survival (DFS) compared to follow-up observation in patients with resected pancreatic cancer at high risk of recurrence or metastasis after adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Postoperative Adjuvant Therapy, Maintenance Therapy
- What is being tested?
- S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Jul 2028
- Phase
- Phase 4
- 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
- Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);
- Meets one of the following conditions: Pathologically confirmed as moderately differentiated, moderately to poorly differentiated, or poorly differentiated; or pathologic staging as: T3N0M0, T1-3N1-2M0, T4N0-2M0; or one or more surgical margins are R1 resected (R0 resection if no tumor cells are found more than 1mm from the margin, otherwise R1 resection); or involvement of the portal vein and/or superior mesenteric vein resection; or pre-adjuvant chemotherapy CA19-9 > 90 U/mL; or pre-adjuvant chemotherapy ctDNA testing positive;
- Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);
- Eligible for oral medication;
- Age ≥18 and ≤75, male or female;
- ECOG performance status: 0 to 2;
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- Normal function of major organs as per the following criteria within 14 days prior to starting treatment:① Neutrophil count ≥ 1.5×10^9/L;② Platelet count ≥ 75×10^9/L;③ Hemoglobin ≥ 9.0 g/dL;④ AST ≤ 2.5×UNL (upper normal limit) (if liver metastasis present, AST ≤ 5×UNL);⑤ ALT ≤ 2.5×UNL (if liver metastasis present, ALT ≤ 5×UNL);⑥ Total bilirubin ≤ 1.5×UNL;⑦ Creatinine clearance (calculated using the Cockcroft-Gault formula) > 60 mL/min or serum creatinine ≤ 1.5×UNL;
- Women of childbearing potential must have used reliable contraception within 7 days prior to enrollment and have a negative pregnancy test, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of the investigational drug. For men, they must be surgically sterile or agree to use appropriate contraception during the study and for 3 months after treatment;
- Expected survival time ≥6 months;
- Voluntary participation in the study, signed informed consent, and demonstrated good compliance and cooperation during follow-up.
Who cannot join
- Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;
- Incomplete macroscopic resection (R2 resection);
- Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;
- CA19-9 > 180 U/mL within 21 days before enrollment;
- Severe liver dysfunction (AST/ALT > 3.5 times the upper limit of normal, alkaline phosphatase > 6 times the upper limit of normal), with liver drainage;
- Known peripheral neuropathy (CTCAE ≥ Grade 2);
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- Participation in another clinical trial of cytotoxic drugs, targeted therapies, immunotherapies, etc., within the past 4 weeks, or received systemic chemotherapy, radiotherapy, or biological therapy within the past 4 weeks;
- Concurrent or metachronous cancers with disease-free survival ≥ 5 years (excluding pancreatic cancer), except for cancers that have been cured or can be potentially cured with local excision (e.g., esophageal cancer, gastric cancer, colorectal cancer, cervical cancer, non-melanoma skin cancer, bladder cancer);
- Factors that significantly affect oral drug absorption, such as difficulty swallowing, chronic diarrhea, or gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;
- Clinically symptomatic serous effusions (including pleural effusion, ascites, pericardial effusion) requiring symptomatic treatment;
- Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to take effective contraceptive measures;
- Known allergy to the investigational drug, the class of the investigational drug, or its components;
- Need for systemic corticosteroid treatment (except for local steroid pre-treatment);
- History of interstitial lung disease (including interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;
- Active local or systemic infection requiring treatment;
- Heart failure NYHA classification ≥ II or severe heart disease;
- Known HIV infection or history of acquired immunodeficiency syndrome (AIDS) or active hepatitis B or C;
- Toxicity not recovered (CTCAE > Grade 1) or previous anticancer surgery not fully recovered;
- Patients deemed unsuitable for this study by the investigator.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 025
Min Tu, Master, 13585181045, tumin1215@163.com
About this study
Official title: A Real-World Study Comparing Maintenance Chemotherapy With Tegafur, Gimeracil, and Oteracil Potassium (S-1) Versus Follow-Up Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence/Metastasis (MSPAC-1)
The goal of this real-world study is to learn if maintenance chemotherapy with Tegafur, Gimeracil, and Oteracil Potassium (S-1) can improve disease-free survival (DFS) compared to follow-up observation in patients with resected pancreatic cancer at high risk of recurrence or metastasis after adjuvant therapy. The main questions it aims to answer are:
- Does maintenance therapy with S-1 improve disease-free survival (DFS) compared to follow-up observation after standard treatment for resected high-risk pancreatic cancer?
- Does S-1 maintenance therapy improve overall survival (OS), distant disease-free survival (DDFS), and local recurrence-free survival (LRFS) compared to observation?
- What are the safety and tolerability profiles of S-1 maintenance therapy compared to observation? Researchers will compare two groups: the S-1 maintenance therapy group and the observation-only group, to see if S-1 improves survival outcomes and safety.
Read more
Participants will:
- Receive maintenance chemotherapy with S-1 based on body surface area dosing or be assigned to the observation group without drug intervention.
- Undergo imaging evaluations every 12 weeks to monitor for disease recurrence or metastasis.
- Report side effects and any adverse events during the study.
- Being tested
- S-1
- Keywords
- Maintenance Therapy, S-1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Tegafur, Gimeracil, and Oteracil Potassium (S-1) 40-60 mg per dose, orally (p.o.), twice daily (BID), from Day 1 to Day 28, with a 6-week cycle, for a total of 8 cycles; or from Day 1 to Day 14, with a 3-week cycle, for a total of 16 cycles.
| Study group | Role | What they receive |
|---|---|---|
| S-1 Maintenance Therapy | Experimental | S-1 monotherapy Receives: Drug: S-1 |
| Observation Only | No intervention | Participants in this arm will undergo follow-up observation according to the trial protocol, without receiving any antineoplastic drugs for maintenance therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) is defined as the time from enrollment to the first occurrence of disease recurrence or death from any cause, whichever occurs first. If no recurrence occurs during the study, DFS is defined as the time from enrollment to the last confirmed date of disease-free status. For participants who withdraw from the study for reasons other than recurrence (e.g., initiation of other treatments), DFS will be censored at the time of withdrawal or the start of other treatment. For participants who are not censored, pre-planned sensitivity analyses will be conducted based on radiologically confirmed recurrence or death. New primary tumors will not be considered as recurrence events. The confirmed recurrence date will be the date of imaging showing relapse. If recurrence is confirmed through other clinical methods, the date of diagnosis will be used.
Measured: Up to 3 years
Secondary outcomes (5)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrollment to death from any cause. For participants who are alive at the last follow-up, OS will be censored at the last known date of survival. In cases of participants lost to follow-up, OS will be censored at the last date they were confirmed to be alive.
Measured: 5 years
Distant Disease-Free Survival (DDFS)
Distant Disease-Free Survival (DDFS) is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first. If no distant metastasis occurs, DDFS will be defined as the time from enrollment to the last confirmed date of no distant metastasis.
Measured: Up to 3 years
Local Recurrence-Free Survival (LRFS)
Local Recurrence-Free Survival (LRFS) is defined as the time from enrollment to the first occurrence of local recurrence or death from any cause, whichever occurs first. If no local recurrence occurs, LRFS will be defined as the time from enrollment to the last confirmed date of no local recurrence.
Measured: Up to 3 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
This outcome will assess the number of participants who experience treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. These events will be monitored and categorized based on severity, with a focus on the relationship to the study treatment.
Measured: Up to 3 years
Quality of Life (QoL)
Quality of Life will be measured using the EORTC QLQ-C30 (version 3), a widely used instrument to assess the health-related quality of life of cancer patients. The scores will be analyzed to evaluate changes in the quality of life during the study period.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (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 The First Affiliated Hospital with Nanjing Medical UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Tu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779318
- Sponsor's protocol ID
- MSPAC-1
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study Comparing Maintenance Chemotherapy With Tegafur, Gimeracil, and Oteracil Potassium (S-1) Versus Follow-Up Observation After Adjuvant Therapy for Resected Pancreatic Cancer With High Risk of Recurrence/Metastasis (MSPAC-1)
- ClinicalTrials.gov ID
- NCT06779318
- Acronym / sponsor ID
- MSPAC-1
- Keywords
- Maintenance Therapy, S-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 16 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.
The goal of this real-world study is to learn if maintenance chemotherapy with Tegafur, Gimeracil, and Oteracil Potassium (S-1) can improve disease-free survival (DFS) compared to follow-up observation in patients with resected pancreatic cancer at high risk of recurrence or metastasis after adjuvant therapy. The main questions it aims to answer are:
- Does maintenance therapy with S-1 improve disease-free survival (DFS) compared to follow-up observation after standard treatment for resected high-risk pancreatic cancer?
- Does S-1 maintenance therapy improve overall survival (OS), distant disease-free survival (DDFS), and local recurrence-free survival (LRFS) compared to observation?
- What are the safety and tolerability profiles of S-1 maintenance therapy compared to observation? Researchers will compare two groups: the S-1 maintenance therapy group and the observation-only group, to see if S-1 improves survival outcomes and safety.
Participants will:
- Receive maintenance chemotherapy with S-1 based on body surface area dosing or be assigned to the observation group without drug intervention.
- Undergo imaging evaluations every 12 weeks to monitor for disease recurrence or metastasis.
- Report side effects and any adverse events during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1 Maintenance Therapy | Experimental | Drug: S-1S-1 monotherapy |
| Observation Only | No intervention | –Participants in this arm will undergo follow-up observation according to the trial protocol, without receiving any antineoplastic drugs for maintenance therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);
- Meets one of the following conditions: Pathologically confirmed as moderately differentiated, moderately to poorly differentiated, or poorly differentiated; or pathologic staging as: T3N0M0, T1-3N1-2M0, T4N0-2M0; or one or more surgical margins are R1 resected (R0 resection if no tumor cells are found more than 1mm from the margin, otherwise R1 resection); or involvement of the portal vein and/or superior mesenteric vein resection; or pre-adjuvant chemotherapy CA19-9 > 90 U/mL; or pre-adjuvant chemotherapy ctDNA testing positive;
- Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);
- Eligible for oral medication;
- Age ≥18 and ≤75, male or female;
Key exclusion criteria (19 listed)
- Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;
- Incomplete macroscopic resection (R2 resection);
- Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;
- CA19-9 > 180 U/mL within 21 days before enrollment;
- Severe liver dysfunction (AST/ALT > 3.5 times the upper limit of normal, alkaline phosphatase > 6 times the upper limit of normal), with liver drainage;
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 |
|---|---|---|
| S-1Tegafur, Gimeracil, and Oteracil Potassium (S-1) 40-60 mg per dose, orally (p.o.), twice daily (BID), from Day 1 to Day 28, with a 6-week cycle, for a total of 8 cycles; or from Day 1 to Day 14, with a 3-week cycle, for a total of 16 cycles. | Drug | S-1 Maintenance Therapy |
Primary outcome
Disease-Free Survival (DFS)
Time frame: Up to 3 years
Disease-Free Survival (DFS) is defined as the time from enrollment to the first occurrence of disease recurrence or death from any cause, whichever occurs first. If no recurrence occurs during the study, DFS is defined as the time from enrollment to the last confirmed date of disease-free status. For participants who withdraw from the study for reasons other than recurrence (e.g., initiation of other treatments), DFS will be censored at the time of withdrawal or the start of other treatment. For participants who are not censored, pre-planned sensitivity analyses will be conducted based on radiologically confirmed recurrence or death. New primary tumors will not be considered as recurrence events. The confirmed recurrence date will be the date of imaging showing relapse. If recurrence is confirmed through other clinical methods, the date of diagnosis will be used.
5 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
Distant Disease-Free Survival (DDFS)
Time frame: Up to 3 years
Local Recurrence-Free Survival (LRFS)
Time frame: Up to 3 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to 3 years
Quality of Life (QoL)
Time frame: Up to 3 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 3 Apr 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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing S-1 in people with Pancreatic Cancer and Postoperative Adjuvant Therapy, run by The First Affiliated Hospital with Nanjing Medical University 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 19 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 3 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: Up to 3 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 3 Apr 2025.