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Trial Title:
SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
NCT ID:
NCT06422156
Condition:
Advanced Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Nimotuzumab
Conditions: Keywords:
advanced pancreatic cancer
stereotactic body radiation therapy (SBRT)
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiation
Description:
Patients will receive SBRT with doses ranging from 35-40 Gy in five fractions.
Arm group label:
SBRT+Nimotuzumab+ mono-chemotherapy
Other name:
SBRT
Intervention type:
Drug
Intervention name:
Nimotuzumab
Description:
Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg on day 1 and 8 of a
21-day cycle until disease progression.
Arm group label:
SBRT+Nimotuzumab+ mono-chemotherapy
Other name:
h-R3
Intervention type:
Drug
Intervention name:
mono-chemotherapy
Description:
Patients will receive mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease
progression.
Arm group label:
SBRT+Nimotuzumab+ mono-chemotherapy
Other name:
chemotherapy
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).
Detailed description:
This clinical study is designed as a prospective, multicenter, single arm study to
evaluate the clinical efficacy and safety of SBRT combined with nimotuzumab and
mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). All
eligible patients will receive SBRT with doses ranging from 35-40 Gy in five fractions,
intravenous nimotuzumab 400mg weekly or 600mg on day 1 and 8 of a 21-day cycle, and
mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression, death,
unacceptable toxicity, or consent withdrawal. The main endpoint is progression-free
survival (PFS).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age 18-75 years old, gender unlimited;
-
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
(PDAC);
-
3. Locally advanced pancreatic cancer (according to the NCCN criteria),
unresectable or surgically declined;
-
4. The maximum diameter of the primary tumor was < 5.0cm;
-
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
-
6. No prior radiotherapy (upper abdomen) or tumor systemic therapy;
-
7. 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;
-
8. Left ventricular ejection fraction ≥50%;
-
9. Fertile subjects are willing to take contraceptive measures during the study
period;
-
10. Woman who are breastfeeding during the study period or within 150 days after
the last treatment;
-
11. Survival was expected to be ≥3 months;
- 12.Good compliance and signed informed consent voluntarily.
Exclusion Criteria:
-
1. Tumor invasion of gastrointestinal tract;
-
2. Woman who are pregnant or breastfeeding;
-
3. History of other malignancies (except cured basal cell carcinoma of the skin
and carcinoma in situ of the cervix) within the past 5 years;
-
4. 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;
- 5.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;
-
6. Patients requiring immunosuppressive;
- 7.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;
-
8. Known allergy to prescription or any component of the prescription used in this
study;
-
9. Immunodeficiency, including HIV infection or other acquired immunodeficiency,
or a history of organ transplantation, or other immune-related disorders
requiring medical intervention;
-
10. Patients with acute and chronic tuberculosis infection;
-
11. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2
weeks prior to initial administration;
- 12.History of noninfectious pneumonia requiring glucocorticoid therapy or current
interstitial lung disease within 1 year prior to initial administration;
-
13. Received any other form of immunosuppressive therapy within 7 days prior to the
initial of study administration;
-
14. Participated in other clinical trials within 4 weeks, or received another
investigational drugs or investigational device within 4 weeks prior to the
initial administration;
- 15.Other reasons that are not suitable to participate in this study according to the
researcher's judgment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Biotech Pharmaceutical Co., Ltd.
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06422156
