Pancreatic CancerPhase 1/2NCT04624217
A Trial of SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Pancreatic Cancer
A Phase 1/2 study testing SHR-1701 in people with Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SHR-1701
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesChina
- Study dates
- 24 Nov 2020to 8 Feb 2023
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged between 18 and 70 years;
- Life expectancy ≥ 12 weeks judged by the investigator.
- The ECOG performance status was 0-1.
- At least 1 measurable lesion conforming to RECIST 1.1 criteria.
- In subjects with histologically or cytologically confirmed pancreatic cancer, there was evidence of inoperable locally advanced or distant metastases.
- Adequate organ and bone marrow function.
- Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study.
- 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
- Known allergy to the study drug or any of its excipients; Or had a serious allergic reaction to other monoclonal antibodies.
- Previous exposure to drugs/antibodies acting on T cell co-stimulation or checkpoint pathways.
- Major surgery within 28 days before the first experimental treatment (biopsy required for diagnosis is permitted).
- Subject with central nervous system (CNS) metastases.
- Had other active malignant tumors within 5 years before entering the study. Except for basal cell or squamous cell carcinomas, superficial bladder carcinomas, carcinoma in situ of the cervix, ductal carcinoma in situ, and papillary carcinoma of the thyroid, which may be treated locally and have been cured.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis.
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- The presence of clinically significant acute or chronic pancreatitis.
- The presence of other acute or chronic infections of clinically significant significance.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: A Phase Ib/II Trial of SHR-1701 Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Subjects With Advanced/Metastatic Pancreatic Cancer
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen.
- Conditions
- Pancreatic Cancer
- Being tested
- SHR-1701
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
Also called Gemcitabine and Albumin Paclitaxel
PDL1/TGFβ
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 | Experimental | SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel Receives: Drug: SHR-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D
Recommended Phase 2 Dose of SHR-1701
Measured: Up to week 3
ORR
Objective Response Rate
Measured: Up to approximately 6 months
Secondary outcomes (6)
Clinically significant toxicity
above grade 3 AEs
Measured: Up to week 3
OS rate
9-month-overall survival rate
Measured: From the start of treatment to 9 months
AEs+SAEs
Adverse Events and Serious Adverse Events
Measured: from the first drug administration to within 90 days for the last SHR-1701 dose
PFS
Progression-Free-Survival
Measured: Up to approximately 6 months
DCR
Disease Control Rate
Measured: Up to approximately 12 months
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
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 posted10 Nov 2020
- Study start24 Nov 2020
- Primary completion16 Sep 2021
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624217
- Sponsor's protocol ID
- SHR-1701-II-204
- Status last verified
- Jan 2024
- First submitted
- 2 Nov 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xue R, Wei M, Yuan J, Li Z, Zhou Y, Xue Z, Wu Y, Han H, Zhou J, Yu X, Shen L. A phase 1b/2 study of first-line anti-PD-L1/ TGF-betaRII fusion protein SHR-1701 combined with nab-paclitaxel and gemcitabine for advanced pancreatic ductal adenocarcinoma. Signal Transduct Target Ther. 2025 Dec 20;10(1):415. doi: 10.1038/s41392-025-02530-2.
PubMed 41422078
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Trial of SHR-1701 Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Subjects With Advanced/Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04624217
- Acronym / sponsor ID
- SHR-1701-II-204
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 10 Nov 2020 (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 SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 | Experimental | Drug: SHR-1701SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged between 18 and 70 years;
- Life expectancy ≥ 12 weeks judged by the investigator.
- The ECOG performance status was 0-1.
- At least 1 measurable lesion conforming to RECIST 1.1 criteria.
- In subjects with histologically or cytologically confirmed pancreatic cancer, there was evidence of inoperable locally advanced or distant metastases.
Key exclusion criteria (9 listed)
- Known allergy to the study drug or any of its excipients; Or had a serious allergic reaction to other monoclonal antibodies.
- Previous exposure to drugs/antibodies acting on T cell co-stimulation or checkpoint pathways.
- Major surgery within 28 days before the first experimental treatment (biopsy required for diagnosis is permitted).
- Subject with central nervous system (CNS) metastases.
- Had other active malignant tumors within 5 years before entering the study. Except for basal cell or squamous cell carcinomas, superficial bladder carcinomas, carcinoma in situ of the cervix, ductal carcinoma in situ, and papillary carcinoma of the thyroid, which may be treated locally and have been cured.
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 |
|---|---|---|
| SHR-1701Also: Gemcitabine and Albumin PaclitaxelPDL1/TGFβ | Drug | SHR-1701 |
Primary outcome
RP2D
Time frame: Up to week 3
Recommended Phase 2 Dose of SHR-1701
ORR
Time frame: Up to approximately 6 months
Objective Response Rate
6 secondary outcomes
Clinically significant toxicity
Time frame: Up to week 3
OS rate
Time frame: From the start of treatment to 9 months
AEs+SAEs
Time frame: from the first drug administration to within 90 days for the last SHR-1701 dose
PFS
Time frame: Up to approximately 6 months
DCR
Time frame: Up to approximately 12 months
OS
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 41422078Xue R, Wei M, Yuan J, Li Z, Zhou Y, Xue Z, Wu Y, Han H, Zhou J, Yu X, Shen L. A phase 1b/2 study of first-line anti-PD-L1/ TGF-betaRII fusion protein SHR-1701 combined with nab-paclitaxel and gemcitabine for advanced pancreatic ductal adenocarcinoma. Signal Transduct Target Ther. 2025 Dec 20;10(1):415. doi: 10.1038/s41392-025-02530-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 SHR-1701 in people with Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D (time frame: Up to week 3). 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?
On the ClinicalTrials.gov record for NCT04624217, which also lists 1 linked publication.
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 2024.