Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.

NCT06840067 | Recruiting

• 1 other identifier: 186698
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer Metastatic; Pancreatic Cancer Non-resectable

Keywords

Carbon Ion Radiotheray; pancreatic cancer; Nimotuzumab; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• overall survival

  overall survival（OS）

  1 year

Secondary Outcomes (2)

• Objective tumor response rate

  1 year

• Progression-free survival

  1year

Study Arms (1)

Single-arm

EXPERIMENTAL

Study group

Radiation: carbon ion radiotherapy (CIRT)

Interventions

carbon ion radiotherapy (CIRT) RADIATION

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.

Also known as: targeted therapy, chemotherapy

Single-arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gansu Wuwei Tumor Hospital: lead

Study Sites (1)

Heavy Ion Radiotherapy Department

Wuwei, Gansu, 733000, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 28961832 BACKGROUND

• Arslan 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.

  PMID: 25083302 BACKGROUND

• Hartimath 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.

  PMID: 30655327 BACKGROUND

• Shinoto 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.

  PMID: 26883565 BACKGROUND

• Shinoto 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.

  PMID: 22744973 BACKGROUND

• 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.

  PMID: 27139057 BACKGROUND

• 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.

  PMID: 21969502 BACKGROUND

• Ciabatti 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.

  PMID: 30270196 BACKGROUND

• Kovac 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.

  PMID: 30254003 BACKGROUND

• Riediger 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.

  PMID: 19418101 BACKGROUND

• Siegel 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.

  PMID: 31912902 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Heavy Ion Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Xiaojun Li

  Gansu Wuwei Tumor Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaojun Li

CONTACT

+8613150160200; anglweli@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)