Pancreatic CancerPhase 2NCT05185869
SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer
A Phase 2 study testing SHR6390, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic 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?
- SHR6390, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female of 18 to 75 years old;
- Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm);
- Subjects are naïve to systemic treatment;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥12 weeks;
- Adequate organ performance based on laboratory blood tests;
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- The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
- Normal swallowing function;
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.
Who cannot join
- Had other active malignant tumors within 5 years before entering the study;
- Confirmed or suspicious new metastatic lesion in brain;
- Subjects are allergy to experimental drugs or any excipients;
- Coagulation disorders (INR>1.5, APTT>ULN);
- Severe pleural effusion or ascites;
- Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
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- Subjects combined with other anti-tumor drugs;
- Chronic diarrhea or intestinal obstruction;
- Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
- Subjects in any trial drug treatment;
- Severe mental disorder;
- Other situations that investigators considered should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Baiyong Shen, Ph.D&M.D, 008602164370045
Baiyong Shen, Ph.D&M.D
About this study
Official title: A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.
Read the detailed description
This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine.
In this research study, the main objectives include:
- Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine.
- Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.
- Conditions
- Pancreatic Cancer
- Being tested
- SHR6390, Nab-paclitaxel, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390Drug
SHR6390, Oral Administration
Nab-paclitaxelDrug
Paclitaxel-albumin, Intravenous Injection
GemcitabineDrug
Gemcitabine, Intravenous Injection
| Study group | Role | What they receive |
|---|---|---|
| AG+SHR6390 | Experimental | Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine Receives: Drug: SHR6390; Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.
Measured: Up to 2 years.
Adverse Events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From the first drugs administration to within 30 days for the last treatment.
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from the first drugs administration to the date of death due to any cause or the last follow ship.
Measured: Up to 2 years.
Progression Free Survival (PFS)
PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship.
Measured: Up to 2 years.
Disease Control Rate (DCR)
DCR is defined as the rate of participants who have achieved complete response, partial response and stable disease.
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (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 Ruijin HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185869
- Sponsor's protocol ID
- PANC-1st-IIT-SHR6390-AG
- Status last verified
- Oct 2021
- First submitted
- 19 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05185869
- Acronym / sponsor ID
- PANC-1st-IIT-SHR6390-AG
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 11 Jan 2022 (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.
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.
Detailed description
This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine.
In this research study, the main objectives include:
- Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine.
- Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AG+SHR6390 | Experimental | Drug: SHR6390, Drug: Nab-paclitaxel, Drug: GemcitabineSubjects will receive SHR6390 plus nab-paclitaxel and gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female of 18 to 75 years old;
- Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm);
- Subjects are naïve to systemic treatment;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥12 weeks;
Key exclusion criteria (12 listed)
- Had other active malignant tumors within 5 years before entering the study;
- Confirmed or suspicious new metastatic lesion in brain;
- Subjects are allergy to experimental drugs or any excipients;
- Coagulation disorders (INR>1.5, APTT>ULN);
- Severe pleural effusion or ascites;
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 |
|---|---|---|
| SHR6390SHR6390, Oral Administration | Drug | AG+SHR6390 |
| Nab-paclitaxelPaclitaxel-albumin, Intravenous Injection | Drug | AG+SHR6390 |
| GemcitabineGemcitabine, Intravenous Injection | Drug | AG+SHR6390 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 2 years.
ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.
Adverse Events (AEs)
Time frame: From the first drugs administration to within 30 days for the last treatment.
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years.
Progression Free Survival (PFS)
Time frame: Up to 2 years.
Disease Control Rate (DCR)
Time frame: Up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR6390, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Ruijin Hospital 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baiyong Shen, Ph.D&M.D (008613901943778, shenby@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 2 years.). 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 11 Jan 2022.