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Locally Advanced or Metastatic Gastric AdenocarcinomaPhase 1/2NCT04572542

Camrelizumab Combined With Apatinib Mesylate Tablets and Nab-paclitaxel in the Second-line Treatment of Advanced Gastric Cancer

A Phase 1/2 study testing Camrelizumab, Apatinib Mesylate and nab-paclitaxel in people with Locally Advanced or Metastatic Gastric Adenocarcinoma, run by The First Affiliated Hospital of Xiamen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate and nab-paclitaxel . Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab, Apatinib Mesylate and nab-paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Jan 2020to 1 Jun 2022
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-70 years of age
  • Gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, sig-ring cell carcinoma sig, poorly differentiated adenocarcinoma por) confirmed by pathology (including histology or cytology) is an unresectable locally advanced or metastatic (stage IV) tumor.
  • For patients with advanced gastric cancer who had received standard first-line treatment in the past, the interval of the last chemotherapy should be more than 1 month .
  • Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter≥15mm，scan slice thicknes 5mm）.
  • ECOG（Eastern Cooperative Oncology Group）:0-2 scores.
  • The expected survival time is more than 3 months.
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  • The damage caused by subjects receiving other treatments has recovered, including receiving nitroso or mitomycin at intervals >=6 weeks; Received other cytotoxic drugs, radiotherapy or surgery >=4 weeks, and the wound had completely healed .
  • Patients with adequate organ function at the time of enrollment as defined below:
  • Blood routine examination standard (without blood transfusion within 14 days before enrollment):
  • HB >=90g/L;
  • WBC >=3.5x10^9/L;
  • ANC >=1.5x10^9/L;
  • PLT >=75x10^9/L;
  • Biochemical examination shall meet the following standards: a.BIL <1.25 ULN; b.ALT and AST< 2.5 ULN; If liver metastasis is present ALT and AST< 5 ULN; c.Serum creatinine Cr <=1 ULN; Serum creatinine >50ml/min (Cockcroft-Gault math);
  • Women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test.
  • Participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.

Who cannot join

  • Patients with chemotherapy and contraindications to Apatinib mesylate.
  • Previous history of receiving purpuranoidins, Apatinib mesylate or other antiangiogenic drugs, Camrelizumab or other immunotherapy.
  • Pregnant or lactating women.
  • Those who participated in other clinical studies and did not recover from toxic reactions within 1 month before enrollment.
  • Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years.
  • Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection
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  • The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases may manifest as the presence of clinical symptoms, cerebral edema, spinal cord compression meningitis, ptosis, and/or progressive growth. After adequate treatment for CNS metastases, neurological symptoms can return to baseline at least 2 weeks prior to randomization (residual signs or symptoms associated with CNS treatment can be enrolled in the study. In addition, subjects must either discontinue corticosteroids or receive prednisone (or an equivalent dose of other corticosteroids) at a steady dose of ≤ 10 mg/d or a gradually reduced dose for at least 2 weeks prior to randomization.
  • The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg)
  • With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male > 450 ms, women > 470 ms) and cardiac insufficiency
  • Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage；coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;
  • Patients with a history of cardiovascular and cerebrovascular diseases who are still taking oral thrombolytic drugs or anticoagulant drugs
  • Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g).
  • Presence of any active, known or suspected autoimmune disease. Allowed to be included in a stable state, do not need systemic immunosuppression treatment of subjects: such as Ⅰ diabetes, only need to hormone replacement therapy for hypothyroidism and without systemic treatment of skin disease (for example, vitiligo, psoriasis, and hair loss).
  • A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation.
  • Patients with other concomitant diseases that, at the investigator's discretion, pose a serious risk to patient safety or affect patient completion of the study.
  • Patients with uncontrolled epilepsy, central nervous system disease, or mental disorders whose clinical severity, as determined by the investigator, may prevent the signing of the informed consent or have multiple factors that affect oral medications (such as inability to swallow, persistent uncontrolled nausea and vomiting, chronic diarrhea, and intestinal obstruction).
  • A person who has previously been allergic to any component of Camrelizumab or to any component of the drug under study.
  • The researchers consider those who were not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Ye feng, Doctor contact

13860458889

yefengdoctor@sina.com

Li jia yi, Doctor contact

13799792820

ljy778848@qq.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

    Ye feng, Doctor, 13860458889, yefengdoctor@sina.com

    Ye feng, Doctor

    Recruiting

Other trials in China

About this study

Official title: Camrelizumab Combined With Apatinib Mesylate Tablets and Nab-paclitaxel in the Second-line Treatment of Advanced Gastric Cancer： a Single-arm, Multicenter， Prospective Phase II Study

To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate and nab-paclitaxel .

Being tested
Camrelizumab, Apatinib Mesylate, nab-paclitaxel

What participants receive

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

  • CamrelizumabDrug

    Camrelizumab One course will last 21 days.Given once every 3 weeks at a dose of 200 mg

  • Apatinib MesylateDrug

    Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday

  • nab-paclitaxelDrug

    nab-paclitaxel One course will last 21 days。Given twice every 3 weeks at a dose of 125 mg/m2

Study groups in NCT04572542
Study groupRoleWhat they receive
Camrelizumab + Apatinib + nab-paclitaxelExperimentalCamrelizumab combined with Apatinib mesylate tablets and nab-paclitaxel in the second-line treatment of advanced gastric cancer
Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate; Drug: nab-paclitaxel

What is being measured

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

  1. Objective response rate

    Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: one year

Secondary outcomes (1)

  1. Disease Control Rate（DCR）

    Disease Control Rate（DCR） according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: one year

Timeline

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

  1. First posted1 Oct 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2022 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04572542
Sponsor's protocol ID
Arise-FJ-G202
Status last verified
Sep 2020
First submitted
25 Sep 2020
Last updated
1 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Camrelizumab, Apatinib Mesylate and nab-paclitaxel in people with Locally Advanced or Metastatic Gastric Adenocarcinoma, run by The First Affiliated Hospital of Xiamen 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 16 inclusion and 18 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 1 Oct 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ye feng, Doctor (13860458889, yefengdoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: one 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 NCT04572542.

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 1 Oct 2020.

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