Pancreatic CancerPhase 1SCART-PNCT07173374

Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study

A Phase 1 study testing SCART Dose Escalation Arm in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Pancreatic Cancer, Locally Advanced Pancreatic Cancer
What is being tested?: SCART Dose Escalation Arm
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 10 Sep 2025to 1 Sep 2028
Phase: Phase 1
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-70 years, male or female. Histologically or cytologically confirmed diagnosis of pancreatic cancer. Locally advanced, unresectable disease without evidence of distant metastasis (based on imaging such as CT/MRI/PET-CT).
Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Adequate bone marrow, liver, and renal function (per laboratory criteria). Life expectancy ≥ 3 months. Signed written informed consent prior to participation.

Who cannot join

Evidence of distant metastasis. Prior abdominal radiotherapy. Prior systemic chemotherapy or immunotherapy within 4 weeks before enrollment. Concurrent participation in another interventional clinical trial. Severe comorbidities (e.g., uncontrolled cardiovascular, pulmonary, or infectious diseases).
Pregnant or breastfeeding women. Known history of other malignancies within the past 5 years (except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ).
Any condition that, in the investigator's judgment, would interfere with patient safety or compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531

Other trials in China

About this study

This is a single-arm, phase I clinical study designed to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) dose escalation in patients with locally advanced pancreatic cancer. Pancreatic cancer carries a dismal prognosis, and the majority of patients are not surgical candidates at diagnosis. Radiotherapy is an important local treatment modality, but conventional approaches have shown limited efficacy. SCART is intended to deliver higher ablative doses to the tumor core while minimizing toxicity to surrounding normal tissues. In this trial, eligible patients will receive SCART with escalating dose levels using a standard 3+3 design. The primary endpoints are to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD). Secondary endpoints include overall survival (OS), local control rate (LCR), and objective response rate (ORR).

Read the detailed description

Pancreatic cancer is among the most aggressive malignancies and is associated with poor prognosis. The 5-year survival rate remains below 10%, and most patients present with unresectable disease at diagnosis. Radiotherapy plays a pivotal role in local disease control, yet conventional fractionated radiotherapy (CFRT) has demonstrated limited survival benefits. Stereotactic body radiotherapy (SBRT) allows delivery of higher biologically effective doses with improved local control, but further dose escalation is restricted by normal tissue tolerance.

SCART (Stereotactic Centralized Ablative Radiation Therapy) is an innovative technique that delivers ablative radiation doses to selected intratumoral sub-volumes while maintaining lower doses at the tumor periphery. This spatial dose distribution has the potential to induce bystander effects and enhance biological efficacy beyond that achievable with uniform SBRT.

This phase I study is designed to evaluate the safety and feasibility of SCART dose escalation in patients with locally advanced pancreatic cancer. Patients will be enrolled into sequential dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region) using a standard 3+3 dose-escalation design. All patients will also receive background SBRT (25 Gy in 5 fractions) covering the gross tumor volume and margin.

The primary objective is to determine dose-limiting toxicities (DLTs) and establish the maximum tolerated dose (MTD) of SCART. Secondary objectives include overall survival (OS), local control rate (LCR), objective response rate (ORR), and treatment-related adverse events (AEs). Exploratory analyses will investigate potential biomarkers and immune response modulation associated with SCART.

The estimated enrollment is 12-24 patients, with an accrual period of 24 months and a minimum follow-up of 12 months.

Conditions: Pancreatic Cancer, Locally Advanced Pancreatic Cancer
Being tested: SCART Dose Escalation Arm
Keywords: SCART, Radiotherapy, Dose Escalation, Phase I Trial
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCART Dose Escalation ArmRadiation
Patients will receive SCART with escalating dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region) using a standard 3+3 design. All patients will also receive background SBRT (25 Gy in 5 fractions) to the gross tumor volume and margin.

Study groups in NCT07173374
Study group	Role	What they receive
SCART Dose Escalation Arm	Experimental	Patients will receive SCART with escalating dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region). Receives: Radiation: SCART Dose Escalation Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD)
The maximum tolerated dose (MTD) of SCART (Stereotactic Centralized Ablative Radiation Therapy) will be determined using a standard 3+3 dose-escalation design. MTD is defined as the highest dose level at which the incidence of dose-limiting toxicities (DLTs), graded according to CTCAE v5.0, does not exceed 33% of patients in that cohort.
Measured: Within 90 days after completion of radiotherapy
Dose-Limiting Toxicities (DLTs)
Incidence of dose-limiting toxicities (DLTs) graded according to the National Cancer Institute Common Terminology CTCAE v5.0. DLTs will be evaluated during the dose-escalation phase to assess the safety of SCART (Stereotactic Centralized Ablative Radiation Therapy).
Measured: Within 90 days after completion of radiotherapy

Secondary outcomes (4)

Overall Survival (OS)
Overall survival will be defined as the time from the start of SCART treatment to death from any cause. Patients still alive at the time of analysis will be censored at the date of last follow-up.
Measured: Up to 12 months after enrollment
Local Control Rate (LCR)
Local tumor control will be assessed according to RECIST v1.1 criteria based on radiographic imaging (CT/MRI). Local control rate will be calculated as the proportion of patients without local progression.
Measured: Up to 12 months after enrollment
Objective Response Rate (ORR)
Objective tumor response will be evaluated using RECIST v1.1 criteria by imaging assessment.
Measured: Up to 12 months after enrollment
Adverse Events (AEs)
Incidence and severity of treatment-related adverse events (AEs) will be graded according to CTCAE v5.0 during and after radiotherapy.
Measured: Up to 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 20251 Sep 2028

First posted15 Sep 2025
Study start10 Sep 2025
Primary completion1 Sep 2028 (estimated)
Study completion1 Sep 2028 (estimated)

Why it stopped: The study was terminated early due to slow patient accrual. Enrollment was substantially lower than anticipated, making it unlikely to achieve the planned sample size within a reasonable timeframe.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Pancreatic CancerStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single-arm, phase I dose-escalation study using a standard 3+3 design to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) in patients with locally advanced pancreatic cancer.
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07173374
Sponsor's protocol ID: SDZLEC2025-283-01
Acronym: SCART-P
Status last verified: Sep 2025
First submitted: 8 Sep 2025
Last updated: 1 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Song CW, Kim MS, Cho LC, Dusenbery K, Sperduto PW. Radiobiological basis of SBRT and SRS. Int J Clin Oncol. 2014 Aug;19(4):570-8. doi: 10.1007/s10147-014-0717-z. Epub 2014 Jul 5.
PubMed 24993673
Gkika E, Firat E, Adebahr S, Graf E, Popp I, Radicioni G, Lo SS, Nestle U, Nicolay NH, Niedermann G, Duda DG, Grosu AL. Systemic immune modulation by stereotactic radiotherapy in early-stage lung cancer. NPJ Precis Oncol. 2023 Mar 2;7(1):24. doi: 10.1038/s41698-023-00358-z.
PubMed 36864234
Timmerman RD, Herman J, Cho LC. Emergence of stereotactic body radiation therapy and its impact on current and future clinical practice. J Clin Oncol. 2014 Sep 10;32(26):2847-54. doi: 10.1200/JCO.2014.55.4675. Epub 2014 Aug 11.
PubMed 25113761
Bouchart C, Navez J, Closset J, Hendlisz A, Van Gestel D, Moretti L, Van Laethem JL. Novel strategies using modern radiotherapy to improve pancreatic cancer outcomes: toward a new standard? Ther Adv Med Oncol. 2020 Jul 7;12:1758835920936093. doi: 10.1177/1758835920936093. eCollection 2020.
PubMed 32684987
Lawlor RT, Mattiolo P, Mafficini A, Hong SM, Piredda ML, Taormina SV, Malleo G, Marchegiani G, Pea A, Salvia R, Kryklyva V, Shin JI, Brosens LA, Milella M, Scarpa A, Luchini C. Tumor Mutational Burden as a Potential Biomarker for Immunotherapy in Pancreatic Cancer: Systematic Review and Still-Open Questions. Cancers (Basel). 2021 Jun 22;13(13):3119. doi: 10.3390/cancers13133119.
PubMed 34206554
Abravan A, Faivre-Finn C, Kennedy J, McWilliam A, van Herk M. Radiotherapy-Related Lymphopenia Affects Overall Survival in Patients With Lung Cancer. J Thorac Oncol. 2020 Oct;15(10):1624-1635. doi: 10.1016/j.jtho.2020.06.008. Epub 2020 Jun 14.
PubMed 32553694
Treatment of locally unresectable carcinoma of the pancreas: comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. Gastrointestinal Tumor Study Group. J Natl Cancer Inst. 1988 Jul 20;80(10):751-5.
PubMed 2898536
Sultana A, Tudur Smith C, Cunningham D, Starling N, Tait D, Neoptolemos JP, Ghaneh P. Systematic review, including meta-analyses, on the management of locally advanced pancreatic cancer using radiation/combined modality therapy. Br J Cancer. 2007 Apr 23;96(8):1183-90. doi: 10.1038/sj.bjc.6603719. Epub 2007 Apr 3.
PubMed 17406358
Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.
PubMed 27139057
Chauffert B, Mornex F, Bonnetain F, Rougier P, Mariette C, Bouche O, Bosset JF, Aparicio T, Mineur L, Azzedine A, Hammel P, Butel J, Stremsdoerfer N, Maingon P, Bedenne L. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Ann Oncol. 2008 Sep;19(9):1592-9. doi: 10.1093/annonc/mdn281. Epub 2008 May 7.
PubMed 18467316
Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. doi: 10.1200/JCO.2011.34.8904. Epub 2011 Oct 3.
PubMed 21969502
Auclin E, Marthey L, Abdallah R, Mas L, Francois E, Saint A, Cunha AS, Vienot A, Lecomte T, Hautefeuille V, de La Fouchardiere C, Sarabi M, Ksontini F, Forestier J, Coriat R, Fabiano E, Leroy F, Williet N, Bachet JB, Tougeron D, Taieb J. Role of FOLFIRINOX and chemoradiotherapy in locally advanced and borderline resectable pancreatic adenocarcinoma: update of the AGEO cohort. Br J Cancer. 2021 Jun;124(12):1941-1948. doi: 10.1038/s41416-021-01341-w. Epub 2021 Mar 26.
PubMed 33772154
Badiyan SN, Molitoris JK, Chuong MD, Regine WF, Kaiser A. The Role of Radiation Therapy for Pancreatic Cancer in the Adjuvant and Neoadjuvant Settings. Surg Oncol Clin N Am. 2017 Jul;26(3):431-453. doi: 10.1016/j.soc.2017.01.012. Epub 2017 May 11.
PubMed 28576181
Fukumura D, Jain RK. Tumor microvasculature and microenvironment: targets for anti-angiogenesis and normalization. Microvasc Res. 2007 Sep-Nov;74(2-3):72-84. doi: 10.1016/j.mvr.2007.05.003. Epub 2007 May 18.
PubMed 17560615
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PubMed 24131140

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stereotactic Centralized Ablative Radiotherapy for Locally Advanced Pancreatic Cancer: A Single-Arm Phase I Safety and Feasibility Study
ClinicalTrials.gov ID: NCT07173374
Acronym / sponsor ID: SCART-P / SDZLEC2025-283-01
Conditions: Pancreatic Cancer, Locally Advanced Pancreatic Cancer
Keywords: SCART, Radiotherapy, Dose Escalation, Phase I Trial
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: The study was terminated early due to slow patient accrual. Enrollment was substantially lower than anticipated, making it unlikely to achieve the planned sample size within a reasonable timeframe.
Enrolment: 24 participants (estimated)
Lead sponsor: Shandong Cancer Hospital and InstituteUniversity, hospital or other
Study start: 10 Sep 2025 (actual)
Primary completion: 1 Sep 2028 (estimated)
Study completion: 1 Sep 2028 (estimated)
First posted: 15 Sep 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.

Detailed description

The estimated enrollment is 12-24 patients, with an accrual period of 24 months and a minimum follow-up of 12 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single-arm, phase I dose-escalation study using a standard 3+3 design to evaluate the safety and feasibility of SCART (Stereotactic Centralized Ablative Radiation Therapy) in patients with locally advanced pancreatic cancer.

Arm	Type	Receives
SCART Dose Escalation Arm	Experimental	Radiation: SCART Dose Escalation ArmPatients will receive SCART with escalating dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age 18-70 years, male or female. Histologically or cytologically confirmed diagnosis of pancreatic cancer. Locally advanced, unresectable disease without evidence of distant metastasis (based on imaging such as CT/MRI/PET-CT).
Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Adequate bone marrow, liver, and renal function (per laboratory criteria). Life expectancy ≥ 3 months. Signed written informed consent prior to participation.

Key exclusion criteria (3 listed)

Evidence of distant metastasis. Prior abdominal radiotherapy. Prior systemic chemotherapy or immunotherapy within 4 weeks before enrollment. Concurrent participation in another interventional clinical trial. Severe comorbidities (e.g., uncontrolled cardiovascular, pulmonary, or infectious diseases).
Pregnant or breastfeeding women. Known history of other malignancies within the past 5 years (except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ).
Any condition that, in the investigator's judgment, would interfere with patient safety or compliance with the study protocol.

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
SCART Dose Escalation ArmPatients will receive SCART with escalating dose cohorts (10 Gy, 13 Gy, 16 Gy, and 19 Gy per fraction within the SCART region) using a standard 3+3 design. All patients will also receive background SBRT (25 Gy in 5 fractions) to the gross tumor volume and margin.	Radiation	SCART Dose Escalation Arm

Primary outcome

Maximum Tolerated Dose (MTD)
Time frame: Within 90 days after completion of radiotherapy
The maximum tolerated dose (MTD) of SCART (Stereotactic Centralized Ablative Radiation Therapy) will be determined using a standard 3+3 dose-escalation design. MTD is defined as the highest dose level at which the incidence of dose-limiting toxicities (DLTs), graded according to CTCAE v5.0, does not exceed 33% of patients in that cohort.
Dose-Limiting Toxicities (DLTs)
Time frame: Within 90 days after completion of radiotherapy
Incidence of dose-limiting toxicities (DLTs) graded according to the National Cancer Institute Common Terminology CTCAE v5.0. DLTs will be evaluated during the dose-escalation phase to assess the safety of SCART (Stereotactic Centralized Ablative Radiation Therapy).

4 secondary outcomes

Overall Survival (OS)
Time frame: Up to 12 months after enrollment
Local Control Rate (LCR)
Time frame: Up to 12 months after enrollment
Objective Response Rate (ORR)
Time frame: Up to 12 months after enrollment
Adverse Events (AEs)
Time frame: Up to 12 months after enrollment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Background: PubMed 24993673Song CW, Kim MS, Cho LC, Dusenbery K, Sperduto PW. Radiobiological basis of SBRT and SRS. Int J Clin Oncol. 2014 Aug;19(4):570-8. doi: 10.1007/s10147-014-0717-z. Epub 2014 Jul 5.
Background: PubMed 36864234Gkika E, Firat E, Adebahr S, Graf E, Popp I, Radicioni G, Lo SS, Nestle U, Nicolay NH, Niedermann G, Duda DG, Grosu AL. Systemic immune modulation by stereotactic radiotherapy in early-stage lung cancer. NPJ Precis Oncol. 2023 Mar 2;7(1):24. doi: 10.1038/s41698-023-00358-z.
Background: PubMed 25113761Timmerman RD, Herman J, Cho LC. Emergence of stereotactic body radiation therapy and its impact on current and future clinical practice. J Clin Oncol. 2014 Sep 10;32(26):2847-54. doi: 10.1200/JCO.2014.55.4675. Epub 2014 Aug 11.
Background: PubMed 32684987Bouchart C, Navez J, Closset J, Hendlisz A, Van Gestel D, Moretti L, Van Laethem JL. Novel strategies using modern radiotherapy to improve pancreatic cancer outcomes: toward a new standard? Ther Adv Med Oncol. 2020 Jul 7;12:1758835920936093. doi: 10.1177/1758835920936093. eCollection 2020.
Background: PubMed 34206554Lawlor RT, Mattiolo P, Mafficini A, Hong SM, Piredda ML, Taormina SV, Malleo G, Marchegiani G, Pea A, Salvia R, Kryklyva V, Shin JI, Brosens LA, Milella M, Scarpa A, Luchini C. Tumor Mutational Burden as a Potential Biomarker for Immunotherapy in Pancreatic Cancer: Systematic Review and Still-Open Questions. Cancers (Basel). 2021 Jun 22;13(13):3119. doi: 10.3390/cancers13133119.
Background: PubMed 32553694Abravan A, Faivre-Finn C, Kennedy J, McWilliam A, van Herk M. Radiotherapy-Related Lymphopenia Affects Overall Survival in Patients With Lung Cancer. J Thorac Oncol. 2020 Oct;15(10):1624-1635. doi: 10.1016/j.jtho.2020.06.008. Epub 2020 Jun 14.
Background: PubMed 2898536Treatment of locally unresectable carcinoma of the pancreas: comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. Gastrointestinal Tumor Study Group. J Natl Cancer Inst. 1988 Jul 20;80(10):751-5.
Background: PubMed 17406358Sultana A, Tudur Smith C, Cunningham D, Starling N, Tait D, Neoptolemos JP, Ghaneh P. Systematic review, including meta-analyses, on the management of locally advanced pancreatic cancer using radiation/combined modality therapy. Br J Cancer. 2007 Apr 23;96(8):1183-90. doi: 10.1038/sj.bjc.6603719. Epub 2007 Apr 3.
Background: PubMed 27139057Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.
Background: PubMed 18467316Chauffert B, Mornex F, Bonnetain F, Rougier P, Mariette C, Bouche O, Bosset JF, Aparicio T, Mineur L, Azzedine A, Hammel P, Butel J, Stremsdoerfer N, Maingon P, Bedenne L. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Ann Oncol. 2008 Sep;19(9):1592-9. doi: 10.1093/annonc/mdn281. Epub 2008 May 7.
Background: PubMed 21969502Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. doi: 10.1200/JCO.2011.34.8904. Epub 2011 Oct 3.
Background: PubMed 33772154Auclin E, Marthey L, Abdallah R, Mas L, Francois E, Saint A, Cunha AS, Vienot A, Lecomte T, Hautefeuille V, de La Fouchardiere C, Sarabi M, Ksontini F, Forestier J, Coriat R, Fabiano E, Leroy F, Williet N, Bachet JB, Tougeron D, Taieb J. Role of FOLFIRINOX and chemoradiotherapy in locally advanced and borderline resectable pancreatic adenocarcinoma: update of the AGEO cohort. Br J Cancer. 2021 Jun;124(12):1941-1948. doi: 10.1038/s41416-021-01341-w. Epub 2021 Mar 26.
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.

Jinbo Yue, Doctor principal investigator

Shandong Cancer Hospital and Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCART Dose Escalation Arm in people with Pancreatic Cancer and Locally Advanced Pancreatic Cancer, run by Shandong Cancer Hospital and Institute 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 2 inclusion and 3 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: paused, as of the sponsor's last update on 1 May 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Maximum Tolerated Dose (MTD) (time frame: Within 90 days after completion of radiotherapy). The study lists 2 primary outcomes in all. 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 NCT07173374, which also lists 20 linked publications.

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 1 May 2026.