TreatmentNCT04603586
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
A study testing SBRT and Chemotherapy in people with Treatment, run by Changhai Hospital at 2 sites in China.
Trial summary
The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (<70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment
- What is being tested?
- SBRT and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesChina
- Study dates
- 10 Nov 2020to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cytologically or histologically verified pancreatic adenocarcinoma
- Imaging examinations confirmed locally advanced pancreatic cancer
- No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy
- ECOG of 0 to1
- Age of 18 years or older
- Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1.5×10^9 cells/L, leukocyte count≥ 3.5×10^9 cells/L, platelets ≥ 70×10^9 cells/L, hemoglobin ≥ 8.0 g/dl
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- Adequate liver and renal, defined as: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL, creatinine < 2.0 mg/dL, AST<2.5 × ULN (Upper Limit of Normal) (0-64U/L), ALT<2.5 × ULN (0-64U/L)
- Adequate blood clotting function, defined as: international normalized ratio (INR) < 2 (0.9-1.1)
- Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Who cannot join
- Previously receiving radiotherapy, immunotherapy or targeted therapy
- Evidences of metastatic disease confirmed by chest CT or PET-CT
- ECOG ≥2
- Age <18 years
- Secondary malignancy
- Abnormal results of blood routine examinations and liver and kidney and coagulation tests
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- Patients with active inflammatory bowel diseases or peptic ulcer
- Gastrointestinal bleeding or perforation within 6 months
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Medical history of symptomatic congestive heart failure: New York Heart Association Class III to IV
- Medical history of respiratory insufficiency
- Women who are pregnant or breastfeeding
- Participation in another clinical treatment trial
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
Trial locations and contacts
2 sites in 1 country.
China2 sites
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (<70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer
The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (<70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
SBRT: in 5-6 fractions with CyberKnife
ChemotherapyDrug
Gemcitabine 1000mg/m^2 and nab-paclitaxel 125mg/m^2, administered intravenously, on day 1 and 8 of a 21-day cycle for six cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | SBRT of BED<70Gy combined with Gemcitabine + albumin-bound paclitaxel Receives: Radiation: SBRT; Drug: Chemotherapy |
| Arm B | Experimental | SBRT of BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel Receives: Radiation: SBRT; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
Progression-Free-Survival
Measured: 3 years
Secondary outcomes (2)
Adverse Events
Adverse events
Measured: 3 years
Overall Survival
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start10 Nov 2020
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Changhai 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603586
- Sponsor's protocol ID
- Changhai Hospit
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2020
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ye Y, Zhu X, Zhao X, Jiang L, Cao Y, Zhang H. Biologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial. BMJ Open. 2022 Aug 29;12(8):e049382. doi: 10.1136/bmjopen-2021-049382.
PubMed 36038164
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase Ⅱ Clinical Study of Stereotactic Radiotherapy Combined With Chemotherapy With Different Biological Effective Doses (<70gy vs. >70Gy) in Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04603586
- Acronym / sponsor ID
- Changhai Hospit
- Conditions
- Treatment
- Keywords
- SBRT, Locally Advanced Pancreatic Cancer, Biological Effective Dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (<70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the toxicity of radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Radiation: SBRT, Drug: ChemotherapySBRT of BED<70Gy combined with Gemcitabine + albumin-bound paclitaxel |
| Arm B | Experimental | Radiation: SBRT, Drug: ChemotherapySBRT of BED >70Gy combined with Gemcitabine + albumin-bound paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cytologically or histologically verified pancreatic adenocarcinoma
- Imaging examinations confirmed locally advanced pancreatic cancer
- No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy
- ECOG of 0 to1
- Age of 18 years or older
Key exclusion criteria (14 listed)
- Previously receiving radiotherapy, immunotherapy or targeted therapy
- Evidences of metastatic disease confirmed by chest CT or PET-CT
- ECOG ≥2
- Age <18 years
- Secondary malignancy
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 |
|---|---|---|
| SBRTSBRT: in 5-6 fractions with CyberKnife | Radiation | Arm A, Arm B |
| ChemotherapyGemcitabine 1000mg/m^2 and nab-paclitaxel 125mg/m^2, administered intravenously, on day 1 and 8 of a 21-day cycle for six cycles | Drug | Arm A, Arm B |
Primary outcome
Progression-Free-Survival
Time frame: 3 years
Progression-Free-Survival
2 secondary outcomes
Adverse Events
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36038164Ye Y, Zhu X, Zhao X, Jiang L, Cao Y, Zhang H. Biologically effective doses of 60-70Gy versus >70Gy of stereotactic body radiotherapy (SBRT) combined with chemotherapy in locally advanced pancreatic cancer: protocol of a single-centre, phase II clinical trial. BMJ Open. 2022 Aug 29;12(8):e049382. doi: 10.1136/bmjopen-2021-049382.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT and Chemotherapy in people with Treatment, run by Changhai Hospital at 2 sites 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603586, which also lists 1 linked publication.
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 20 Oct 2025.