SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer

NCT06422156 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: M2023639
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC).

Conditions

Advanced Pancreatic Cancer

Keywords

advanced pancreatic cancer; stereotactic body radiation therapy (SBRT); Nimotuzumab

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  Up to 12 months

Secondary Outcomes (5)

• overall survival (OS)

  Up to 12 months

• Objective response rate (ORR)

  Up to 12 months

• Disease control rate (DCR)

  Up to 12 months

• Pain relief rate

  Up to 12 months

• adverse events

  Up to 30 days after last administration

Study Arms (1)

SBRT+Nimotuzumab+ mono-chemotherapy

EXPERIMENTAL

All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.

Radiation: Stereotactic body radiation; Drug: Nimotuzumab; Drug: mono-chemotherapy

Interventions

Stereotactic body radiation RADIATION

Patients will receive SBRT with doses ranging from 35-40 Gy in five fractions.

Also known as: SBRT

SBRT+Nimotuzumab+ mono-chemotherapy

Nimotuzumab DRUG

Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg on day 1 and 8 of a 21-day cycle until disease progression.

Also known as: h-R3

SBRT+Nimotuzumab+ mono-chemotherapy

mono-chemotherapy DRUG

Patients will receive mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression.

Also known as: chemotherapy

SBRT+Nimotuzumab+ mono-chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-75 years old, gender unlimited;
• \. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
• \. Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined;
• \. The maximum diameter of the primary tumor was \< 5.0cm;
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• \. No prior radiotherapy (upper abdomen) or tumor systemic therapy;
• \. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN;
• \. Left ventricular ejection fraction ≥50%;
• \. Fertile subjects are willing to take contraceptive measures during the study period;
• \. Woman who are breastfeeding during the study period or within 150 days after the last treatment;
• \. Survival was expected to be ≥3 months;
• Good compliance and signed informed consent voluntarily.

You may not qualify if:

• \. Tumor invasion of gastrointestinal tract;
• \. Woman who are pregnant or breastfeeding;
• \. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years;
• \. History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence;
• Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months;
• \. Patients requiring immunosuppressive;
• Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease;
• \. Known allergy to prescription or any component of the prescription used in this study;
• \. Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention;
• \. Patients with acute and chronic tuberculosis infection;
• \. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration;
• History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
• \. Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration;
• \. Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration;
• Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Biotech Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Interventions

Radiosurgery; nimotuzumab; Drug Therapy

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Junjie Wang, Dr

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Qiu, MD

CONTACT

+86 010-82265968; qiubin@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share