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Pancreatic Cancer Stage IVNCT04181645

SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer

A study testing Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin in people with Pancreatic Cancer Stage IV, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer Stage IV
What is being tested?
Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
29 Jun 2019to 1 May 2023
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged >= 18 years, male or female;
  • Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma;
  • Patients have never received systematical anti-cancer therapy;
  • Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.)
  • ECOG:0-1;
  • Expected survival>=12 weeks;
  • Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):
  • 1) Absolute neutrophil count(ANC) >= 1.5x10^9/L 2) Platelet >= 85x10^9/L 3) Hemoglobin >= 90g/L 4) Serum Albumin >= 30g/L 5) Total bilirubin <= 2.0 ULN (Biliary obstructive patients after biliary drainage <= 2.5 ULN), AST and ALT <= 3.0 ULN (patients with liver metastasis <= 5 ULN); 6) Creatinine clearance rate >60 mL/min; 7) Activated Partial Thromboplastin Time and International Standardized Ratio <= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)

Who cannot join

  • Patients with central nervous system metastasis.
  • Patients only have local advanced diseases.
  • Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage.
  • Patients with history of allergy to monoclonal antibodies, any component of SHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.
  • Patients have ever received anti PD-1 or anti PD-L1 therapy in the past.
  • Patients have accepted any experimental medication.within 4 weeks before the first dose of our experimental medication administration.
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  • Patients are enrolled in another clinical trial except for observational clinical trial (Non-interventional) or the follow-up of the interventional clinical trial.
  • Patients accepted the last dose of anti-cancer therapy (including radiotherapy) within 4 weeks before the first dose of experimental medication administration.
  • Patients who need corticosteroid or other immunosuppressive agents.
  • Patients who ever received anti-cancer vaccine or have received live vaccine within 4 weeks before the first dose of administration.
  • Patients who have received major surgery within 4 weeks before the first dose of administration.
  • Patients with active autoimmune diseases, history of autoimmune diseases.
  • History of immunodeficiency, including HIV positive test, or other acquired, congenital immunodeficiency disorders, or history of organ transplantation and allogeneic bone marrow transplantation.
  • Patients with uncontrolled cardiovascular clinical symptoms or diseases.
  • Severe infections occurred within 4 weeks before the first administration.
  • History of interstitial lung disease and non- infectious pneumonia.
  • Patients with active pulmonary tuberculosis (APTB) infection confirmed by medical history or CT examination.
  • Patients with active hepatitis B or hepatitis C.
  • Patients with any other malignant tumors diagnosed within 5 years before the first administration.
  • Pregnant or lactating women.
  • According to the researchers, participants have other factors that may force them to end up the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • RenJiH

    Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC.

Read the detailed description

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC.

PD-1 antibody SHR-1210 is a humanized monoclonal antibody, and the heavy chain is immunoglobulin G4 (IgG4), the light chain is immunoglobulin κ (IgK). SHR-1210 specifically binds to PD-1 and blocks the interaction of PD-1 with its ligand (PD-L1), allowing T cells to recover against tumor immune responses.

The safety of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related adverse events (AEs), or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.

Tumor response will be assessed by radiographic examination in screening visit and every 2 cycles after first dose.

Being tested
Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin
Keywords
pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albuminDrug

    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. Gemcitabine Other Name: Gemcitabine Hydrochloride for Injection Paclitaxel-albumin Other Name: Paclitaxel-albumin Injection

Study groups in NCT04181645
Study groupRoleWhat they receive
SHR-120, Paclitaxel-albumin and GemcitabineExperimentalSubjects receive SHR-1210 200mg (Day 1) and Paclitaxel-albumin 125mg/m2 (Day1 and Day8) and gemcitabine 1000mg/m2 (Day 1 and Day 8) of each 21-day cycle for at most 6 cycles until documented PD or intolerable adverse event or new anti-cancer treatment or loss to follow-up or death. Subjects receive SHR-1210 200mg (Day1) to maintain after 6 cycles treatment without PD or listed situation to terminate.
Receives: Drug: Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR：Objective Response Rate by IRC

    objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1

    Measured: through study completion, an average of 2 year

Secondary outcomes (5)

  1. ORR：Objective Response Rate by investigator

    objective response rate evaluated by investigator using radiographic examination according to RECIST1.1

    Measured: through study completion, an average of 2 year

  2. DCR: disease control rate

    partial rate of subjects evaluated as CR/PR/SD in all subjects

    Measured: through study completion, an average of 2 year

  3. DoR：duration of response

    time firstly evaluated as CR or PR to time firstly evaluated as PD

    Measured: through study completion, an average of 2 year

  4. PFS: progression-free survival

    time from randomization to progression

    Measured: through study completion, an average of 2 year

  5. OS: overall survival

    time from randomization to death

    Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2019
  2. Study start29 Jun 2019
  3. Primary completion1 Dec 2021
  4. Study completion1 May 2023

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients will be assigned to accept the combination treatment of SHR-120 with Paclitaxel-albumin and gemcitabine after meeting the inclusion criteria.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04181645
Sponsor's protocol ID
CPOG1210-003
Status last verified
Apr 2024
First submitted
25 Nov 2019
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jiujie Cui, Haiyan Yang, Jiong Hu, Jiayu Yao, Yu Wang, Yiyi Liang, Yongchao Wang, Feng Jiao, Xiaofei Zhang, Xiao Zhang, Ting Han, Tiebo Mao, Qing Xia, Xiuying Xiao, Li-Wei Wang. Anti-PD-1 antibody combined with albumin-bound paclitaxel and gemcitabine (AG) as first-line therapy and Anti-PD-1 monotherapy as maintenance in metastatic pancreatic ductal adenocarcinoma (PDAC). J Clin Oncol 39, 2021 (suppl 15; ASCO2021 abstr e16218).

Questions about this trial

What is this clinical trial studying?

A study testing Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin in people with Pancreatic Cancer Stage IV, run by RenJi 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 8 inclusion and 21 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 3 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.

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?

ORR：Objective Response Rate by IRC (time frame: through study completion, an average of 2 year). 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 NCT04181645, 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 3 Apr 2024.

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