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Advanced Gastric CancerPhase 1/2NCT04286711

Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in Advanced Gastric Cancer

A Phase 1/2 study testing Albumin-paclitaxel, Apatinib, Camrelizumab in people with Advanced Gastric Cancer, run by China Medical University, China 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is to evaluate the tolerance of albumin paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Albumin-paclitaxel, Apatinib, Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
Mar 2020to Jun 2021
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

  • Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma (GEJ).
  • Age: 18-70 years old, Female or Male.
  • Failure or intolerance of first-line chemotherapy which requires that the first-line chemotherapy regimen include the scheme based on platinum and / or fluorouracil drugs.
  • ECOG performance status 0-1.
  • Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. If the progress is confirmed and meets the RECIST 1.1 standard, it can also be used as target lesion.
  • An expected survival of > 12 weeks.
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  • Be able to swallow tablets normally.
  • All acute toxic reactions caused by previous anti-tumor treatment or surgery were relieved to level 0-1 (according to NCI CTCAE version 4.03) or to the level specified in the inclusion / exclusion criteria. Except for other toxicity that researchers think does not pose a safety risk to patients, such as hair loss.
  • Has adequate sufficient organ and bone marrow functions.
  • Fertile female subjects must undergo a serum-negative pregnancy test within 72 hours before starting the study drug and must agree to use a medically approved effective contraceptive during the study period and within 90 days of the last dose of the study drug; Male subjects whose partners are women of child-bearing age should undergo surgical sterilization or agree to use effective methods of contraception during the study period and within 90 days of the last study administration.
  • Patients have agreed and signed the informed consent. Willingness and able to follow the planned visit, research treatment, laboratory examination and other test procedures.

Who cannot join

  • Known HER2 positive status.
  • The first-line received any taxol drug treatment (if there is tumor recurrence and metastasis during or ≤ 24 weeks after the completion of adjuvant treatment, it is considered that the early-stage adjuvant treatment is a first-line systemic chemotherapy for advanced diseases).
  • Previously received PD-1 / PD-L1 antibody, CTLA-4 antibody, or other small molecular inhibitors for PD-1 / PD-L1 and / or VEGFR.
  • It is known that it is allergic to apatinib, albumin paclitaxel, carrizumab or drug adjuvant; or it has serious allergic reaction to other monoclonal antibodies.
  • Immunosuppressive drugs were used within 14 days before the first use of carrizumab, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids in physiological dose of the same drug).
  • The live attenuated vaccine shall be inoculated within 4 weeks before the first administration or during the study period.
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  • Central nervous system (CNS) metastasis or presence of brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth. Patients with central nervous system metastases that have been stable for more than 1 month after surgery or radiotherapy can be enrolled in the study if their clinical manifestations are stable 4 weeks after withdrawal of anticonvulsants and steroids before the first administration of the study.
  • The peripheral neuropathy was more than 1 grade.
  • Symptomatic, disseminated to the internal organs, and at risk of life-threatening complications in a short period of time (including patients with uncontrolled large amount of exudate [chest, pericardium, abdominal cavity], lymphangitis and more than 30% of liver involvement).
  • At present, patients with interstitial pneumonia or interstitial lung disease, or with previous history of interstitial pneumonia or interstitial lung disease requiring hormone treatment, or with other pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and treatment of immune-related pulmonary toxicity, or with active pneumonia on CT at screening stage Patients with severe impairment of pulmonary function; active tuberculosis.
  • There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.)
  • Any other malignant tumor has been diagnosed within 3 years before the study, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ which has been fully treated.
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C.
  • Within 6 months before the study, the following conditions occurred: myocardial infarction, severe / unstable angina, NYHA grade 2 or above cardiac insufficiency, supraventricular or ventricular arrhythmia requiring drug control (including QTc interval > 450 ms for men and 470 MS for women), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).
  • Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
  • Abnormal coagulation (INR > 1.5 or APTT > 1.5 × ULN), bleeding tendency or undergoing thrombolysis or anticoagulation.
  • endencies, such as hemophilia, coagulation skill disorder, thrombocytopenia, hypersplenism and so on.
  • Patients with obvious cough blood or hemoptysis of half teaspoon (2.5ml) or more per day within 2 months before entering the study.
  • In the first 3 months of the study, patients who had significant clinical bleeding symptoms or had definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer and positive stool occult blood monitoring twice in the baseline period, should be excluded from gastric bleeding by gastroscope.
  • Events of arteriovenous thrombosis (AVT) occurred within 6 months before the study, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.
  • Long term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥ 300 mg / day or clopidogrel > 75 mg / day) is required.
  • Active infection (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs) or fever of unknown origin > 38.5 ° C 2 weeks ago (except for tumor related fever determined by researchers).
  • The history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known.
  • Participated in any other drug clinical study within 4 weeks before the first administration, or within 5 half lives from the last study.
  • A history of psychoactive substance abuse or abuse is known.
  • The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study.

Trial locations and contacts

1 site in 1 country.

YunPeng Liu, PhD contact

86-24-83282312

cmuliuyunpeng@hotmail.com

Xiujuan Qu, PhD contact

86-24-83282542

qu_xiujuan@hotmail.com

China1 site

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110010

    Yunpeng Liu, PhD, 86-24-83282312, cmuliuyunpeng@hotmail.com

    Xiujuan Qu, PhD, 86-24-83282542, qu_xiujuan@hotmail.com

Other trials in China

About this study

Official title: Phase I / II Clinical Study of Albumin-paclitaxel Combined With Apatinib and Camrelizumab in the Second-line Treatment of Advanced Gastric Cancer

This study is to evaluate the tolerance of albumin paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination.

Read the detailed description

This is a Single arm, open, phase I / II clinical trial. The study was divided into tolerance observation stage (dose exploration stage) and efficacy expansion stage (dose expansion stage).

This study is to evaluate the tolerance of albumin-paclitaxel combined with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer to determine the maximum tolerable dose (MTD) of the combination.

The secondary objective was to evaluate the safety and efficacy of albumin- paclitaxel in combination with apatinib and Camrelizumab in the second-line treatment of advanced gastric cancer.

Being tested
Albumin-paclitaxel, Apatinib, Camrelizumab
Keywords
Apatinib Albumin-paclitaxel Camrelizumab Gastric cancer

What participants receive

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

  • Albumin-paclitaxel, Apatinib, CamrelizumabDrug

    Also called Paclitaxel for injection（Albumin Bound），Apatinib Mesylate Tablets，SHR-1210

    Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8, Repeat the therapeutic schedule every 3 weeks; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day, Q3W;

Study groups in NCT04286711
Study groupRoleWhat they receive
Albumin-paclitaxel Combined With Apatinib and CamrelizumabExperimentalAlbumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day; Repeat the therapeutic schedule every 3 weeks
Receives: Drug: Albumin-paclitaxel, Apatinib, Camrelizumab

What is being measured

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

  1. Dose-Limiting Toxicity [DLT]

    Dose-Limiting Toxicity

    Measured: Each 21 days up to Dose-Limiting Toxicity (12-13 months)

Secondary outcomes (7)

  1. Incidence and degree of Adverse Events and Serious Adverse Events [Safety]

    Incidence and degree of Adverse Events and Serious Adverse Events

    Measured: Until 30 day safety follow-up visit (Up to 14-18 months)

  2. Objective Response Rate [ORR]

    Objective Response Rate

    Measured: Up to 13-16 months

  3. Duration of response [DoR]

    Duration of response

    Measured: Up to 13-16 months

  4. Time To Response [TTR]

    Time To Response

    Measured: Up to 13-16 months

  5. Disease Control Rate [DCR]

    Disease Control Rate

    Measured: Up to13-16 months

  6. Progression Free Survival [PFS]

    Progression Free Survival

    Measured: Up to 13-16 months

  7. Overall Survival [OS]

    Overall Survival

    Measured: Up to 14-18 months

Timeline

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

  1. First posted27 Feb 2020
  2. Study startMar 2020 (estimated)
  3. Primary completionAug 2020 (estimated)
  4. Study completionJun 2021 (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
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04286711
Sponsor's protocol ID
MA-GC-I-002
Status last verified
Feb 2020
First submitted
25 Feb 2020
Last updated
27 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

    PubMed 18172173

  • Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.

    PubMed 18971936

  • Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

    PubMed 23918952

  • Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.

    PubMed 21742485

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Albumin-paclitaxel, Apatinib, Camrelizumab in people with Advanced Gastric Cancer, run by China Medical University, China 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 11 inclusion and 26 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 27 Feb 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 YunPeng Liu, PhD (86-24-83282312, cmuliuyunpeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity [DLT] (time frame: Each 21 days up to Dose-Limiting Toxicity (12-13 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 NCT04286711, which also lists 5 linked publications.

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 27 Feb 2020.

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