Pancreatic Cancer MetastaticNCT06840067
Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.
A study testing carbon ion radiotherapy (CIRT) in people with Pancreatic Cancer Metastatic and Pancreatic Cancer Non-resectable, run by Gansu Wuwei Tumor Hospital at 1 site in China.
Trial summary
The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Metastatic, Pancreatic Cancer Non-resectable
- What is being tested?
- carbon ion radiotherapy (CIRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤80 years;
- Indications: patients with locally advanced or metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology (stage III - IV).
- At least one measurable lesion was present according to RECIST version 1.1 evaluation criteria.
- Suitable for one cycle of gemcitabine combined with nituzumab.
- No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);
- Liver function, kidney function and bone marrow function were basically normal (ALT and AST < 1.5 times of high normal value (ULN), bilirubin < 1.5×ULN; Adult endogenous creatinine clearance rate of 60ml/min or serum creatinine SCR≤140μmoI/L, BUN≤6.8mmol/L; Hemoglobin level >9 g/dL; White blood cell count ≥3.0*109/L; Platelet count ≥100*109/L;)
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- Good physical condition, i.e. ECOG (Eastern United States Oncology Collaboration Group) 0~2; There were no complications such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, and severe chronic heart disease that may affect radiotherapy. Cardiac function grade 1. (According to the New York College of Cardiology Cardiac Function Scale (NYHA)
- Adequate functions of major organs;
- Predicted survival (after treatment) ≥3 months;
- Informed consent has been signed by the patient or his legal representative before radiotherapy.
Who cannot join
- Patients who have received monoclonal antibodies, EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressants within six months.
- Patients with uncontrolled, cancerous pleural effusion requiring frequent drainage, pericardial effusion, or ascites (allowing for cytological confirmation of effusion), gastrointestinal bleeding, or those identified by the investigator as having a high blood risk within 14 days prior to admission.
- Participated in other interventional clinical trials within 30 days prior to screening.
- The dose limit for organs at risk cannot reach the preset safe dose limit.
- Being on chronic steroid hormone therapy for more than 6 months (e.g., prednisone dose > 10 mg/ day or equivalent).
- People who are allergic to the drugs or their ingredients used in this program.
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- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
- Persons with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis;
- Accompanied by serious comorbiditions, including uncontrolled systemic or co-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), drug or alcohol abuse, dependence, addiction, and/or mental illness that prevent the successful implementation of the trial protocol;
- Patients with poor compliance, including those who may not be able to complete the treatment plan or receive prescribed follow-up and examination;
- Patients had other malignant neoplasms (except cured skin cancer and stage 0 cervical cancer);
- There are contraindications to radiotherapy;
- having no or limited capacity for civil conduct;
- Any medical history that, in the investigator's judgment, might interfere with the trial results or increase the patient's risk;
- Any condition in which the physician considers that participation in the trial is not appropriate, the physician determines that the patient will not benefit from carbon ion radiotherapy, or that there are other co-existing conditions or other factors that may affect carbon ion therapy.
- Inability to understand the purpose of treatment or unwillingness/inability to sign treatment consent.
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, 1 recruiting
- Recruiting
Heavy Ion Radiotherapy Department
Wuwei, Gansu, 733000
Xiaojun Li, +8613150160200, anglweli@qq.com
About this study
Official title: Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.
The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.
Read the detailed description
The objective is a single-center, single-arm, prospective Phase II clinical trial was conducted to evaluate the safety and efficacy of this regimen.
The primary criteria for inclusion were 18 to 80 years of age, histologically or cytologically confirmed pancreatic ductal adenocarcinoma, and clinician assessment as inoperable or patient rejection of manual surgery. All eligible patients will receive CIRT in combination with gemcitabine and nituzumab. The primary endpoint of the study was progression-free survival (PFS). All patients included in the study were followed for survival for at least 12 months. A safe and effective segmentation dose for pancreatic cancer suitable for our facility and RBE model was obtained. The comprehensive treatment of carbon ion radiation therapy, targeted therapy and chemotherapy is effective of refractory tumors, radiation-resistant tumors, and complex tumors. Using the physical dosimetry and biological advantages of heavy ions, we can improve the tumor control rate and reduce the occurrence of surrounding normal tissue damage, and provide new treatment suggestions for locally advanced and metastatic pancreatic cancer.
- Being tested
- carbon ion radiotherapy (CIRT)
- Keywords
- Carbon Ion Radiotheray, pancreatic cancer, Nimotuzumab, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion radiotherapy (CIRT)Radiation
Also called targeted therapy, chemotherapy
1.CIRT: GTV: Primary tumor visible on imaging and clinical examination, and involved regional lymph nodes identified by CT/MRI (≥1.0 cm) or PET/CT scan. CTV: GTV plus 5mm margin, include posterior peritoneal plexus area and elective node irradiation around the pancreas (ENI). PTV: CTV plus 2.5-5mm margin (depending on the system error of each unit; When pancreatic head cancer is close to the stomach and intestines, the gastrointestinal direction does not expand). ITV: delineated on 4D-CT considering the influence of respiratory activity. Prescription dose: Stratification by measuring the nearest distance between PTV and gastrointestinal tract (≥5mm or < 5mm); Pancreatic head cancer (distance < 5mm) : 52.8Gy(RBE)/4.4Gy/12Fx; Pancreatic head, body and tail cancer (≥5mm) : 57.2Gy(RBE)/4.4Gy/13Fx. CIRT was once a day, four or five times a week. 2.Chemotherapy:Gemcitabine 1000mg/m2, intravenous infusion, dl, d8; Q3w . 3.Targeted therapyNituzumab injection 400mg, Qw，at least 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Study group Receives: Radiation: carbon ion radiotherapy (CIRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival（OS）
Measured: 1 year
Secondary outcomes (2)
Objective tumor response rate
Objective tumor response rate(ORR)
Measured: 1 year
Progression-free survival
Progression-free survival (PFS)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer MetastaticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu Wuwei Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojun Li, Study director, Gansu Wuwei Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840067
- Sponsor's protocol ID
- 186698
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, Berdel WE, Hofheinz R, Behringer DM, Schmidt WE, Goker E, De Dosso S, Kneba M, Yalcin S, Overkamp F, Schlegel F, Dommach M, Rohrberg R, Steinmetz T, Bulitta M, Strumberg D. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol. 2017 Oct 1;28(10):2429-2435. doi: 10.1093/annonc/mdx343.
PubMed 28961832Arslan C, Yalcin S. Current and future systemic treatment options in metastatic pancreatic cancer. J Gastrointest Oncol. 2014 Aug;5(4):280-95. doi: 10.3978/j.issn.2078-6891.2014.030.
PubMed 25083302Hartimath SV, Alizadeh E, Solomon VR, Chekol R, Bernhard W, Hill W, Parada AC, Barreto K, Geyer CR, Fonge H. Preclinical Evaluation of 111In-Labeled PEGylated Maytansine Nimotuzumab Drug Conjugates in EGFR-Positive Cancer Models. J Nucl Med. 2019 Aug;60(8):1103-1110. doi: 10.2967/jnumed.118.220095. Epub 2019 Jan 17.
PubMed 30655327Shinoto M, Yamada S, Terashima K, Yasuda S, Shioyama Y, Honda H, Kamada T, Tsujii H, Saisho H; Working Group for Pancreas Cancer. Carbon Ion Radiation Therapy With Concurrent Gemcitabine for Patients With Locally Advanced Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):498-504. doi: 10.1016/j.ijrobp.2015.12.362. Epub 2015 Dec 20.
PubMed 26883565Shinoto M, Yamada S, Yasuda S, Imada H, Shioyama Y, Honda H, Kamada T, Tsujii H, Saisho H; Working Group for Pancreas Cancer. Phase 1 trial of preoperative, short-course carbon-ion radiotherapy for patients with resectable pancreatic cancer. Cancer. 2013 Jan 1;119(1):45-51. doi: 10.1002/cncr.27723. Epub 2012 Jun 28.
PubMed 22744973Hammel 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 27139057Loehrer 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 21969502Ciabatti S, Cammelli S, Frakulli R, Arcelli A, Macchia G, Deodato F, Cilla S, Giaccherini L, Buwenge M, Morganti AG. Radiotherapy of pancreatic cancer in older patients: A systematic review. J Geriatr Oncol. 2019 Jul;10(4):534-539. doi: 10.1016/j.jgo.2018.09.007. Epub 2018 Sep 28.
PubMed 30270196Kovac JD, Mayer P, Hackert T, Klauss M. The Time to and Type of Pancreatic Cancer Recurrence after Surgical Resection: Is Prediction Possible? Acad Radiol. 2019 Jun;26(6):775-781. doi: 10.1016/j.acra.2018.07.025. Epub 2018 Sep 22.
PubMed 30254003Riediger H, Keck T, Wellner U, zur Hausen A, Adam U, Hopt UT, Makowiec F. The lymph node ratio is the strongest prognostic factor after resection of pancreatic cancer. J Gastrointest Surg. 2009 Jul;13(7):1337-44. doi: 10.1007/s11605-009-0919-2. Epub 2009 May 6.
PubMed 19418101Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT06840067
- Acronym / sponsor ID
- 186698
- Keywords
- Carbon Ion Radiotheray, pancreatic cancer, Nimotuzumab, Gemcitabine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Gansu Wuwei Tumor HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Feb 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 objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.
Detailed description
The objective is a single-center, single-arm, prospective Phase II clinical trial was conducted to evaluate the safety and efficacy of this regimen.
The primary criteria for inclusion were 18 to 80 years of age, histologically or cytologically confirmed pancreatic ductal adenocarcinoma, and clinician assessment as inoperable or patient rejection of manual surgery. All eligible patients will receive CIRT in combination with gemcitabine and nituzumab. The primary endpoint of the study was progression-free survival (PFS). All patients included in the study were followed for survival for at least 12 months. A safe and effective segmentation dose for pancreatic cancer suitable for our facility and RBE model was obtained. The comprehensive treatment of carbon ion radiation therapy, targeted therapy and chemotherapy is effective of refractory tumors, radiation-resistant tumors, and complex tumors. Using the physical dosimetry and biological advantages of heavy ions, we can improve the tumor control rate and reduce the occurrence of surrounding normal tissue damage, and provide new treatment suggestions for locally advanced and metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Radiation: carbon ion radiotherapy (CIRT)Study group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤80 years;
- Indications: patients with locally advanced or metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology (stage III - IV).
- At least one measurable lesion was present according to RECIST version 1.1 evaluation criteria.
- Suitable for one cycle of gemcitabine combined with nituzumab.
- No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);
Key exclusion criteria (16 listed)
- Patients who have received monoclonal antibodies, EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressants within six months.
- Patients with uncontrolled, cancerous pleural effusion requiring frequent drainage, pericardial effusion, or ascites (allowing for cytological confirmation of effusion), gastrointestinal bleeding, or those identified by the investigator as having a high blood risk within 14 days prior to admission.
- Participated in other interventional clinical trials within 30 days prior to screening.
- The dose limit for organs at risk cannot reach the preset safe dose limit.
- Being on chronic steroid hormone therapy for more than 6 months (e.g., prednisone dose > 10 mg/ day or equivalent).
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 |
|---|---|---|
| carbon ion radiotherapy (CIRT)Also: targeted therapy, chemotherapy1.CIRT: GTV: Primary tumor visible on imaging and clinical examination, and involved regional lymph nodes identified by CT/MRI (≥1.0 cm) or PET/CT scan. CTV: GTV plus 5mm margin, include posterior peritoneal plexus area and elective node irradiation around the pancreas (ENI). PTV: CTV plus 2.5-5mm margin (depending on the system error of each unit; When pancreatic head cancer is close to the stomach and intestines, the gastrointestinal direction does not expand). ITV: delineated on 4D-CT considering the influence of respiratory activity. Prescription dose: Stratification by measuring the nearest distance between PTV and gastrointestinal tract (≥5mm or < 5mm); Pancreatic head cancer (distance < 5mm) : 52.8Gy(RBE)/4.4Gy/12Fx; Pancreatic head, body and tail cancer (≥5mm) : 57.2Gy(RBE)/4.4Gy/13Fx. CIRT was once a day, four or five times a week. 2.Chemotherapy:Gemcitabine 1000mg/m2, intravenous infusion, dl, d8; Q3w . 3.Targeted therapyNituzumab injection 400mg, Qw，at least 4-6 cycles. | Radiation | Single-arm |
Primary outcome
overall survival
Time frame: 1 year
overall survival（OS）
2 secondary outcomes
Objective tumor response rate
Time frame: 1 year
Progression-free survival
Time frame: 1year
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 25 Mar 2025.
- Background: PubMed 28961832Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, Berdel WE, Hofheinz R, Behringer DM, Schmidt WE, Goker E, De Dosso S, Kneba M, Yalcin S, Overkamp F, Schlegel F, Dommach M, Rohrberg R, Steinmetz T, Bulitta M, Strumberg D. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol. 2017 Oct 1;28(10):2429-2435. doi: 10.1093/annonc/mdx343.
- Background: PubMed 25083302Arslan C, Yalcin S. Current and future systemic treatment options in metastatic pancreatic cancer. J Gastrointest Oncol. 2014 Aug;5(4):280-95. doi: 10.3978/j.issn.2078-6891.2014.030.
- Background: PubMed 30655327Hartimath SV, Alizadeh E, Solomon VR, Chekol R, Bernhard W, Hill W, Parada AC, Barreto K, Geyer CR, Fonge H. Preclinical Evaluation of 111In-Labeled PEGylated Maytansine Nimotuzumab Drug Conjugates in EGFR-Positive Cancer Models. J Nucl Med. 2019 Aug;60(8):1103-1110. doi: 10.2967/jnumed.118.220095. Epub 2019 Jan 17.
- Background: PubMed 26883565Shinoto M, Yamada S, Terashima K, Yasuda S, Shioyama Y, Honda H, Kamada T, Tsujii H, Saisho H; Working Group for Pancreas Cancer. Carbon Ion Radiation Therapy With Concurrent Gemcitabine for Patients With Locally Advanced Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):498-504. doi: 10.1016/j.ijrobp.2015.12.362. Epub 2015 Dec 20.
- Background: PubMed 22744973Shinoto M, Yamada S, Yasuda S, Imada H, Shioyama Y, Honda H, Kamada T, Tsujii H, Saisho H; Working Group for Pancreas Cancer. Phase 1 trial of preoperative, short-course carbon-ion radiotherapy for patients with resectable pancreatic cancer. Cancer. 2013 Jan 1;119(1):45-51. doi: 10.1002/cncr.27723. Epub 2012 Jun 28.
- 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 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 30270196Ciabatti S, Cammelli S, Frakulli R, Arcelli A, Macchia G, Deodato F, Cilla S, Giaccherini L, Buwenge M, Morganti AG. Radiotherapy of pancreatic cancer in older patients: A systematic review. J Geriatr Oncol. 2019 Jul;10(4):534-539. doi: 10.1016/j.jgo.2018.09.007. Epub 2018 Sep 28.
- Background: PubMed 30254003Kovac JD, Mayer P, Hackert T, Klauss M. The Time to and Type of Pancreatic Cancer Recurrence after Surgical Resection: Is Prediction Possible? Acad Radiol. 2019 Jun;26(6):775-781. doi: 10.1016/j.acra.2018.07.025. Epub 2018 Sep 22.
- Background: PubMed 19418101Riediger H, Keck T, Wellner U, zur Hausen A, Adam U, Hopt UT, Makowiec F. The lymph node ratio is the strongest prognostic factor after resection of pancreatic cancer. J Gastrointest Surg. 2009 Jul;13(7):1337-44. doi: 10.1007/s11605-009-0919-2. Epub 2009 May 6.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- 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.
Xiaojun Li study director
Gansu Wuwei Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon ion radiotherapy (CIRT) in people with Pancreatic Cancer Metastatic and Pancreatic Cancer Non-resectable, run by Gansu Wuwei Tumor 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 16 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 25 Mar 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.
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 Xiaojun Li (+8613150160200, anglweli@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 1 year). 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 NCT06840067, which also lists 11 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 25 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.