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Gastric AdenocarcinomaPhase 2NCT04190745

Toripalimab Combined With Apatinib Mesylate for the Treatment of Gastric Adenocarcinoma in a Prospective Randomized Multicenter Phase II Clinical Study

A Phase 2 study testing Toripalimab+Apatinib mesylate and paclitaxel in people with Gastric Adenocarcinoma, run by Zhejiang Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Preclinical studies have shown that Toripalimab and Nivolumab and Pembrolizumab have similar safety but better in vivo efficacy than target monoclonal antibody candidates with different sequence characteristics.In addition, apatinib mesylate is a small-molecule drug that can target VEGFR and is itself a powerful… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Toripalimab+Apatinib mesylate and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteChina
Study dates
29 Nov 2019to Jun 2024
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

  • Have fully understood the study and voluntarily signed the informed consent (ICF);
  • Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, except siwert I type;
  • Previously received an anti-tumor drug therapy for advanced gastric adenocarcinoma and identified tumor progression or intolerance to existing chemotherapy regimens; If the radical surgery accompanied by adjuvant or neoadjuvant chemotherapy recurred or metastasized within 6 months after the end of the study, the patients could be enrolled in this study.
  • At least one measurable lesion (according to RECIST 1.1);
  • Agree to provide previously stored tumor tissue specimens or biopsy to collect tumor lesion tissues and send them to the central laboratory for pd-l1 IHC test;
  • Age from 18 to 75, regardless of gender;
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  • ECOG score 0-1;
  • Expected survival time ≥3 months;
  • The laboratory inspection value must meet the following criteria within 7 days prior to enrollment:
  • neutrophils ≥1.5×109/L;
  • platelet ≥75×109/L;
  • hemoglobin ≥90g/L (no infusion of concentrated red blood cells within 2 weeks);
  • serum creatinine ≤1.5× the upper normal ULN, or creatinine clearance >50 mL/min;
  • serum total bilirubin ≤1.5×ULN (subjects with gilbert syndrome are allowed to have total bilirubin ≤3×ULN);
  • AST and ALT ≤2.5×ULN;For subjects with liver metastasis, ALT and AST≤5×ULN;
  • Within 28 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraception during study drug use and within 60 days after the last dose. In this program, women of childbearing age are defined as sexually mature women: 1) women who have not undergone hysterectomy or bilateral ovariectomies; 2) women who have not experienced continuous natural menopause for 24 months (amenorrhea does not exclude fertility after cancer treatment) (i.e.* female spouses of male subjects should also follow the above contraceptive requirements if they are of childbearing age.

Who cannot join

  • Those who are known to be allergic to the components of the experimental drug;
  • Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibody), immunotherapy (such as interleukin-2 or interferon), or other study drug therapy within the first 4 weeks of enrollment;
  • Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment;
  • Received radiotherapy within 4 weeks before enrollment, or received radiotherapy with radioactive drugs within 8 weeks, except local palliative radiotherapy for bone metastasis;
  • Major surgery was performed or not fully recovered from the previous surgery within the first 4 weeks of enrollment (the definition of major surgery refers to the level 3 and level 4 surgery as stipulated in the administrative measures for clinical application of medical technology implemented on May 1, 2009);
  • The toxicity of previous anti-tumor therapy has not recovered to CTCAE grade 0-1, except the following:
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  • loss of hair;
  • pigmentation;
  • peripheral neurotoxicity has been restored to <CTCAE level 2;
  • Long-term toxicity caused by radiotherapy cannot be recovered according to the judgment of the researcher;
  • Subjects with clinical symptoms of central nervous system metastasis (such as brain edema, need for hormone intervention, or progression of brain metastasis) or cancerous meningitis.Subjects who have received previous brain or meningeal metastasis treatment, if clinical stability has been maintained for at least 2 months, and who have stopped systemic sex hormone therapy (>10mg/ day prednisone or other effective hormones) for more than 4 weeks can be included;
  • Previous or present coexisting malignancies (except well-controlled basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other well-controlled malignancies that have not been treated in the past five years);
  • The subject has any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism and hypothyroidism;Subjects with vitiligo or asthma that had been completely relieved in childhood and who did not need any intervention in adulthood were included.Asthma that requires a bronchodilator for medical intervention is not included);
  • Previous use of anti-pd-1 antibody, anti-pd-l1 antibody, anti-pd-l2 antibody or anti-ctla-4 antibody (or any other antibody acting on the T cell synergistic stimulation or checkpoint pathway);
  • Her2+ positive patients who had not received trastuzumab treatment in the past
  • Subjects with active tuberculosis (TB) were receiving anti-tb treatment or had received anti-tb treatment within 1 year before screening;
  • Comorbiditis requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses (>10mg/d prednisone or other therapeutic hormones);
  • Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
  • pregnant or lactating women;
  • HIV positive;
  • HBsAg positive and HBV DNA copy number positive (quantitative detection ≥1000cps/ml);
  • Positive blood screening for chronic Hepatitis c (HCV antibody positive);
  • Any other disease or condition of clinical significance that the investigator considers may affect protocol compliance or the subject's signing of an informed consent form (ICF), or is not appropriate to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country.

Ying J er, Doctor contact

13858195803

jieerying@aliyun.com

China1 site, 1 recruiting

  • Jieer Ying

    Hangzhou, Zhejiang, 310000

    Ying J er, Dr., 13858195803

    Recruiting

Other trials in China

About this study

Official title: Zhejiang Cancer Hospital

Preclinical studies have shown that Toripalimab and Nivolumab and Pembrolizumab have similar safety but better in vivo efficacy than target monoclonal antibody candidates with different sequence characteristics.In addition, apatinib mesylate is a small-molecule drug that can target VEGFR and is itself a powerful therapeutic drug for gastric cancer, so we designed a clinical trial of apatinib combined with toripalimab monoclonal antibody.The study focused on 12 month OS rate, progression-free survival (PFS), clinical objective response rate (ORR), and drug safety.The study was an open, multicenter, randomized controlled clinical trial with a 1:1 distribution of trial and control groups.It is expected that 58 people will be included in the experimental group and 58 people in the control group.

Being tested
Toripalimab+Apatinib mesylate, paclitaxel

What participants receive

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

  • Toripalimab+Apatinib mesylateDrug

    Toripalimab 240mg, ivgtt, Q3w Apatinib mesylate 250mg PO. QD

  • paclitaxelDrug

    paclitaxel 80mg/m2, q3w

Study groups in NCT04190745
Study groupRoleWhat they receive
The control groupExperimentalNot described
Receives: Drug: paclitaxel
The experimental groupExperimentalNot described
Receives: Drug: Toripalimab+Apatinib mesylate

What is being measured

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

  1. Subjects' Overall survival rate at 12 months

    Overall survival rate

    Measured: 12 months

Timeline

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

  1. First posted9 Dec 2019
  2. Study start29 Nov 2019
  3. Primary completionSep 2023 (estimated)
  4. Study completionJun 2024 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190745
Sponsor's protocol ID
IRB-2019-155
Status last verified
Dec 2019
First submitted
3 Dec 2019
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wei Q, Xu X, Li J, Wang C, Chen W, Xie Y, Luo C, Chen L, Chu J, Wu W, Han Z, Yang Y, Hu Z, Xu Q, Ying J. Apatinib Plus Toripalimab (Anti-PD1 Therapy) as Second-Line Therapy in Patients With Advanced Gastric or Esophagogastric Junction Cancer: Results From a Randomized, Open-Label Phase II Study. Oncologist. 2024 Apr 4;29(4):364-e578. doi: 10.1093/oncolo/oyae005.

    PubMed 38366886

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab+Apatinib mesylate and paclitaxel in people with Gastric Adenocarcinoma, run by Zhejiang Cancer 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 16 inclusion and 23 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 9 Dec 2019. 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 Ying J er, Doctor (13858195803, jieerying@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects' Overall survival rate at 12 months (time frame: 12 months). 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 NCT04190745, 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 9 Dec 2019.

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