Trial Title:
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
NCT ID:
NCT06370754
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Leucovorin
Paclitaxel
Gemcitabine
Fluorouracil
Irinotecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JS001
Description:
240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.
Arm group label:
Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)
Arm group label:
Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine
Arm group label:
Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine
Arm group label:
Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine
Other name:
Toripalimab
Intervention type:
Drug
Intervention name:
JS004
Description:
200 mg by IV infusion Q3W, given on cycle day 1.
Arm group label:
Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)
Arm group label:
Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine
Intervention type:
Drug
Intervention name:
JS007
Description:
3mg/kg by IV infusion Q3W, given on cycle day 1.
Arm group label:
Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine
Intervention type:
Drug
Intervention name:
JS015
Description:
600mg by IV infusion Q3W, given on cycle day 1.
Arm group label:
Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine
Intervention type:
Drug
Intervention name:
Irinotecan Liposome Injection
Description:
60 or 70 mg/m^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.
Arm group label:
Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)
Arm group label:
Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV
Intervention type:
Drug
Intervention name:
5-Fluorouracil (5-FU)
Description:
2400mg/m^2, intravenously, over 46 h on day 1, Q2W.
Arm group label:
Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)
Arm group label:
Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV
Intervention type:
Drug
Intervention name:
Leucovorin (LV)
Description:
400mg/m^2, intravenously, over 30 min on day 1, Q2W.
Arm group label:
Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV)
Arm group label:
Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV
Arm group label:
Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
125 mg/m^2 by IV infusion Q3W, given on cycle day 1 and 8.
Arm group label:
Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine
Arm group label:
Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine
Arm group label:
Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000 mg/m^2 by IV infusion Q3W, given on cycle day 1 and 8.
Arm group label:
Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine
Arm group label:
Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine
Arm group label:
Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine
Summary:
This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety
of different novel immunotherapies in patients with advanced pancreatic cancer.
Detailed description:
The cohort A/B/C included patients with unresectable locally advanced or metastatic
pancreatic cancer who had previously failed at least first line gemcitabine-based system
therapy.The cohort D/E/F included patients with previously untreated systemic pancreatic
cancer with unresectable locally advanced or metastatic pancreatic cancer.This study
plans to first explore A/B/C cohort, and then start the D/E/F cohort after determining
the safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary participation, written informed consent, complied well and cooperated with
the follow-up visits;
- Age ≥ 18 years old, female or male individuals;
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1, the
expected survival is more than 3 months;
- Patients with locally advanced unresectable or metastatic pancreatic cancer
confirmed by histopathology or cytopathology (islet cell tumor is not eligible for
inclusion) who meet the following requirements:
- For the A/B/C/ cohort: Had failed of at least first-line systemic therapy;
disease recurrence or progression within 6 months of the last treatment of
neoadjuvant or adjuvant chemotherapy was also allowed to be enrolled;
- For the D/E/F cohort: No prior systemic treatment; patients with recurrence or
progression of disease more than 6 months after the last treatment of
neoadjuvant or adjuvant chemotherapy were also allowed to be enrolled;
- Had at least one measurable lesion according to RECIST v1.1.
- Patients had adequate major organs function;
- Women of childbearing potential must undergo serum pregnancy test within 7 days
prior to the first dose and the result must be negative. Female subjects of
childbearing potential and male subjects whose partners are women of childbearing
potential must agree to use highly effective contraceptive methods during the study
period and within 180 days after the last dose of study drug.
Exclusion Criteria:
- Previously received drugs with the same target as the planned investigational
therapy;
- radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy,
immunotherapy, or molecular targeted therapy within 4 weeks prior to initial
administration, except for bisphosphonates (which can be used for bone metastasis);
- Uncontrolled central nervous system metastases (meaning symptoms or the use of
glucocorticoids or mannitol to control symptoms);
- A history of clinically significant or uncontrolled heart disease, including
congestive heart failure, angina pectoris, myocardial infarction, or ventricular
arrhythmia, in the 6 months prior to initial dosing;
- Patients with Grade 1 and above adverse reactions caused by previous treatment,
including Grade 1 peripheral neurotoxicity; hair loss is not included and the
investigator should clearly record the reasons;
- Malignant tumors within 5 years prior to the first dose (except for cured skin basal
cell carcinoma and cervical carcinoma in situ);
- Active autoimmune disease requiring systemic treatment within 2 years prior to first
administration, except for vitiligo, type I diabetes, residual hypothyroidism due to
autoimmune thyroiditis requiring hormone replacement therapy only;
- History of rapid allergic reaction, eczema or asthma that cannot be controlled by
topical corticosteroids;
- Patients who have lung disease, such as drug-induced interstitial lung disease or
pneumonia, obstructive pulmonary disease that severely affects lung function, and
symptomatic bronchospasm;
- Serious infections requiring antibiotic treatment within 14 days prior to initial
administration (>CTCAE grade 2), such as severe pneumonia, bacteremia,
comorbidifications, etc., resulting in the need for hospitalization;
- Vaccination of live vaccine within 4 weeks before the first dose or during the study
period;
- Known human immunodeficiency virus (HIV) infection, allogeneic organ transplantation
or allogeneic hematopoietic stem cell transplantation;
- History of prior allergy to any component or excipient of the investigational drug
to be received;
- Other conditions assessed by the investigator as unsuitable for participation in the
trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
April 30, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06370754
