Pancreatic CancerPhase 1/2FD-IMPACTNCT06370754
Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
A Phase 1/2 study testing JS001, JS004 and JS007 in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- JS001, JS004 and JS007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Apr 2027
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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);
Show all 14Show fewer
- 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.
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
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- JS001, JS004, JS007, JS015, Irinotecan Liposome Injection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS001Drug
Also called Toripalimab
240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.
JS004Drug
200 mg by IV infusion Q3W, given on cycle day 1.
JS007Drug
3mg/kg by IV infusion Q3W, given on cycle day 1.
JS015Drug
600mg by IV infusion Q3W, given on cycle day 1.
Irinotecan Liposome InjectionDrug
60 or 70 mg/m^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.
5-Fluorouracil (5-FU)Drug
2400mg/m^2, intravenously, over 46 h on day 1, Q2W.
Leucovorin (LV)Drug
400mg/m^2, intravenously, over 30 min on day 1, Q2W.
Nab paclitaxelDrug
125 mg/m^2 by IV infusion Q3W, given on cycle day 1 and 8.
GemcitabineDrug
1000 mg/m^2 by IV infusion Q3W, given on cycle day 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV) | Experimental | Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS004 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs. Receives: Drug: JS001; Drug: JS004; Drug: Irinotecan Liposome Injection; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV) |
| Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV | Experimental | Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS007 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs. Receives: Drug: JS001; Drug: JS007; Drug: Irinotecan Liposome Injection; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV) |
| Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV | Experimental | Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS015 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs. Receives: Drug: JS001; Drug: JS015; Drug: Irinotecan Liposome Injection; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV) |
| Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine | Experimental | Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS004 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs. Receives: Drug: JS001; Drug: JS004; Drug: Nab paclitaxel; Drug: Gemcitabine |
| Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine | Experimental | Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS007 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs. Receives: Drug: JS001; Drug: JS007; Drug: Nab paclitaxel; Drug: Gemcitabine |
| Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine | Experimental | Participants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS015 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs. Receives: Drug: JS001; Drug: JS015; Drug: Nab paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) (phase IB)
If less than 2 participants developed DLT during the safety observation period (one cycle after the first dose), follow-up first-line D/E/F cohort exploration should be considered. Otherwise, it is up to the investigator to decide the next research plan.
Measured: 21 days after the first dose was administered to each subject
Objective Response Rate (ORR) (phase II)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.
Measured: Up to 1 year
Secondary outcomes (6)
Objective Response Rate (ORR) (phase IB)
ORR was defined as the percentage of participants with a best overall response of CR or PR based on RECIST 1.1.
Measured: Up to 1 year
Disease control rate (DCR)
DCR was defined as the percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable based on RECIST 1.1.
Measured: Up to 1 year
Duration of Response (DOR)
DOR will be calculated from the date of the first evaluation showing PR, or CR, to the date of the first disease progression or death, whichever comes first and based on RECIST 1.1.
Measured: Up to 1 year
Progression free survival (PFS)
PFS is defined as the time from the first dose until objective tumor progression(PD), or death, whichever comes first and based on RECIST 1.1. At the end of the study, the time of last acquisition of living patients without PD was taken as the deleted data.
Measured: Up to 2 years
Overall Survival (OS)
OS will be measured from the date of first dose to death from any cause.
Measured: Up to 2 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Adverse event (AE), abnormal laboratory examination, serious adverse event (SAE) related with the study drug judged using NCI-CTCAE V5.0 by investigator.
Measured: 90 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370754
- Sponsor's protocol ID
- 2401289-19-2403
- Acronym
- FD-IMPACT
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment
- ClinicalTrials.gov ID
- NCT06370754
- Acronym / sponsor ID
- FD-IMPACT / 2401289-19-2403
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Apr 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV) | Experimental | Drug: JS001, Drug: JS004, Drug: Irinotecan Liposome Injection, Drug: 5-Fluorouracil (5-FU), Drug: Leucovorin (LV)Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS004 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs. |
| Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV | Experimental | Drug: JS001, Drug: JS007, Drug: Irinotecan Liposome Injection, Drug: 5-Fluorouracil (5-FU), Drug: Leucovorin (LV)Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS007 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs. |
| Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV | Experimental | Drug: JS001, Drug: JS015, Drug: Irinotecan Liposome Injection, Drug: 5-Fluorouracil (5-FU), Drug: Leucovorin (LV)Participants with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy will receive JS015 and JS001 combined with chemotherapy (irinotecan liposome injection+5-FU/LV) until the treatment termination event specified in the protocol occurs. |
| Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine | Experimental | Drug: JS001, Drug: JS004, Drug: Nab paclitaxel, Drug: GemcitabineParticipants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS004 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs. |
| Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine | Experimental | Drug: JS001, Drug: JS007, Drug: Nab paclitaxel, Drug: GemcitabineParticipants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS007 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs. |
| Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine | Experimental | Drug: JS001, Drug: JS015, Drug: Nab paclitaxel, Drug: GemcitabineParticipants with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer will receive JS015 and JS001 combined with chemotherapy (nab-paclitaxel+gemcitabine) until the treatment termination event specified in the protocol occurs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Had at least one measurable lesion according to RECIST v1.1.
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| JS001Also: Toripalimab240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1. | Drug | Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV), Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine, Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine, Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine |
| JS004200 mg by IV infusion Q3W, given on cycle day 1. | Drug | Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV), Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine |
| JS0073mg/kg by IV infusion Q3W, given on cycle day 1. | Drug | Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine |
| JS015600mg by IV infusion Q3W, given on cycle day 1. | Drug | Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine |
| Irinotecan Liposome Injection60 or 70 mg/m^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1. | Drug | Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV), Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV |
| 5-Fluorouracil (5-FU)2400mg/m^2, intravenously, over 46 h on day 1, Q2W. | Drug | Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV), Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV |
| Leucovorin (LV)400mg/m^2, intravenously, over 30 min on day 1, Q2W. | Drug | Cohort1: JS004+JS001+Irinotecan Liposome Injection+5-fluorouracil (5-FU)/leucovorin (LV), Cohort2: JS007+JS001+Irinotecan Liposome Injection+5-FU/LV, Cohort3: JS015+JS001+Irinotecan Liposome Injection+5-FU/LV |
| Nab paclitaxel125 mg/m^2 by IV infusion Q3W, given on cycle day 1 and 8. | Drug | Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine, Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine, Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine |
| Gemcitabine1000 mg/m^2 by IV infusion Q3W, given on cycle day 1 and 8. | Drug | Cohort4: JS004+JS001+Nab-Paclitaxel+Gemcitabine, Cohort5: JS007+JS001+Nab-Paclitaxel+Gemcitabine, Cohort6: JS015+JS001+ Nab-Paclitaxel+Gemcitabine |
Primary outcome
Incidence of dose-limiting toxicity (DLT) (phase IB)
Time frame: 21 days after the first dose was administered to each subject
If less than 2 participants developed DLT during the safety observation period (one cycle after the first dose), follow-up first-line D/E/F cohort exploration should be considered. Otherwise, it is up to the investigator to decide the next research plan.
Objective Response Rate (ORR) (phase II)
Time frame: Up to 1 year
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.
6 secondary outcomes
Objective Response Rate (ORR) (phase IB)
Time frame: Up to 1 year
Disease control rate (DCR)
Time frame: Up to 1 year
Duration of Response (DOR)
Time frame: Up to 1 year
Progression free survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 90 days after the last administration
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 17 Apr 2024.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JS001, JS004 and JS007 in people with Pancreatic Cancer, run by Fudan University 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 17 Apr 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xianjun Yu, M.D. (+86-18017317266, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (phase IB) (time frame: 21 days after the first dose was administered to each subject). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.