AzTrials
AzTrials

Metastatic Gastric AdenocarcinomaPhase 2NCT04781686

Apatinib Plus Camrelizumab Combined With Docetaxel and S1 in First-line Treatment for Metastatic Gastric Cancer

A Phase 2 study testing Camrelizumab, Apatinib Mesylate and S1 in people with Metastatic Gastric Adenocarcinoma and Metastatic Gastroesophageal Junction Adenocarcinoma, run by Zhou Fuxiang 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of Apatinib plus Camrelizumab combined with docetaxel and S-1 as the first-line treatment of metastatic adenocarcinoma of gastric and gastroesophageal junction. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab, Apatinib Mesylate and S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
14 May 2021to Aug 2025
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

  • Aged between 18 and 75 years;
  • Has histologically or cytologically diagnosed with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) including gastroesophageal junction adenocarcinoma;
  • Human epidermal growth factor receptor 2 (HER2) negative: immunohistochemical (IHC) - or +; IHC ++ and fluorescence in situ hybridization (FISH) -;
  • No previous systemic therapy (chemotherapy, targeted therapy, immunotherapy, biological therapy, etc.) for GC/GEJ. Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. Anti-tumor traditional Chinese medicine is forbidden within 2 weeks before the first cycle chemotherapy. Patients are allowed to receive palliative radiotherapy (primary tumor or metastasis), but lesions in radiation field cannot be defined as target lesions for assessing objective response, and radiotherapy-related adverse reactions must be restored to at least grade 1；
  • Expected survival time ≥ 3 months;
  • Eastern Cooperative Group (ECOG) performance status score 0 or 1;
Show all 16Show fewer
  • Weight ≥40kg, or BMI>18;
  • 1 measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1;
  • All acute toxic events (excluding hair loss, fatigue and hearing loss) caused by previous anti-tumor treatments or surgery are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified by the inclusion/exclusion criteria of this study；
  • The main organ function of cases should be normal, and meet the following criteria:
  • ① Absolute neutrophil count (ANC)≥1.5×109/L, platelet (PLT) ≥80×109/L;
  • ② Total bilirubin (TBIL) <1.5 upper limit of normal (ULN), ALT (glutamic-pyruvic transaminase）and AST(glutamic-oxalacetic transaminase)≤2.5ULN. For subjects with liver metastases, ALT and AST≤5 ULN, serum Cr≤1.5ULN or endogenous creatinine clearance >50ml /min (Cockcroft-Gault formula);
  • ③ International normalized ratio (INR) <1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN;
  • ④ Urine protein<2+; if urine protein≥2+, the 24-hour urine protein quantitative detection value must be ≤1g;
  • Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and willing to use appropriate contraception during the study period until at least 3 months after the last administration of the test drugs. Non-sterilized males who are sexually active must agree to use adequate contraception during the study period a until at least 3 months after the last administration of the test drugs;
  • Fully understand the study and voluntarily sign the informed consent form (ICF); willing and able to comply with planned visits, treatments, laboratory examinations and other procedures.

Who cannot join

  • HER2 positive cancer: IHC+++, IHC++ and FISH+;
  • Pathological classification of tumor is squamous carcinoma or undifferentiated carcinoma or other types;
  • The interval between disease progression and previous anti-tumor therapy for locally advanced is less than six months;
  • Central nervous system（CNS）metastases with clinical symptoms for example cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth. For subjects with CNS metastases that have been adequately treated, and the neurological symptoms can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to treatment), can be enrolled. In addition, subjects must stop corticosteroids at least 2 weeks before enrollment;
  • Gastrointestinal bleeding that could not be effectively controlled; gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment; arterial/venous thrombosis occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
  • Pleural fluid, ascites, or pericardial effusion that could not be controlled within 7 days before enrollment;
Show all 23Show fewer
  • Weight loss is more than 20% within 2 months before enrollment;
  • Major surgery performed within 28 days before enrollment (tissue biopsy for diagnosis and central venous catheter placement via peripheral vein are allowed). used immunosuppressive drugs within 7 days before enrollment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (≤10 mg/d prednisone or equivalent other kinds of corticosteroids);
  • Other malignancy disease history within five years, with the exception of basal cell carcinoma or squamous carcinoma of skin, superficial bladder carcinoma, and carcinoma in situ (such as Intraductal carcinoma in situ of the breast, cervical cancer in situ, etc.);
  • With history of check point inhibitor treatment, for instance PD-1/PD-L1/ PD-L2/CD137/CTLA-4 antibody agent, and other drug stimulatory or co-inhibitory T-cell receptor;
  • Any active or suspected autoimmune diseases. Subjects who do not require systemic immunosuppressive therapy can be enrolled, such as type I diabetes, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic therapy (such as white scar wind, silver Scourge etc.).
  • Preexisting peripheral neuropathy >Grade 1;
  • Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that may affect the administration and absorption of the drug;
  • Has active infectious diseases, interstitial lung diseases, non-infectious pneumonia, or other systemic diseases that can not be controlled (such as diabetes, hypertension, pulmonary fibrosis, etc.);
  • Has a known history of HIV infection or AIDS. Has a known history of untreated or active hepatitis (active hepatitis B, defined as HBV-DNA>500 IU/ml; active hepatitis C, defined as HCV-RNA higher than the upper limit of the analytical method), or co-infection of HBV and HCV;
  • Hypertension (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg) that cannot be well controlled by antihypertensive drugs.
  • The following conditions occur within 6 months before enrollment: myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestion heart failure;
  • The use of antibiotics> 7 days within 2 weeks before enrollment, or unexplained fever> 38.5°C within 1 week before the treatment of this study (fever caused by tumors can be enrolled);
  • Has an allogenic tissue/solid organ transplant history;
  • Participated in any other clinical trials of drug within 4 weeks before enrollment, or less than 5 half-lives after the last study drug administrated.
  • Be allergic to the study drug or excipients; or have a severe allergic history to other monoclonal antibodies;
  • Has a known history of drug abuse;
  • Has a history or current evidence of any condition that might increase the risk of patients in the present trial, confound the results of the study, interfere with the cases' participation for the full duration of the study, or be not in the best interest of the participant to participate, in the opinion of the investigators.

Trial locations and contacts

1 site in 1 country.

Fuxiang Zhou, M.D. contact

+86-027-67813155

happyzhoufx@sina.com

Huangang Jiang, M.D. contact

+86-027-67813215

hgjiang@whu.edu.cn

China1 site, 1 recruiting

  • Zhongnan Hopital of Wuhan University

    Wuhan, Hubei, 430071

    Fuxiang Zhou, M.D, +86-027-67813155, happyzhoufx@sina.com

    Recruiting

Other trials in China

About this study

Official title: Apatinib Plus Camrelizumab Combined With Docetaxel and S1 in First-line Treatment for Metastatic Gastric Cancer: HCCSC G05 Trial

The purpose of this study is to evaluate the efficacy and safety of Apatinib plus Camrelizumab combined with docetaxel and S-1 as the first-line treatment of metastatic adenocarcinoma of gastric and gastroesophageal junction.

Being tested
Camrelizumab, Apatinib Mesylate, S1, Docetaxel injection

What participants receive

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

  • CamrelizumabDrug

    Also called SHR-1210

    Camrelizumab (200mg) will be given i.v. on day 1 of each 3-week cycle

  • Apatinib MesylateDrug

    Apatinib (250mg) will be administered orally once a day .

  • S1Drug

    S1 (BSA<1.25 40mg, BSA >=1.25-<1.5 50mg, BSA >=1.5 60mg) will be administered orally twice daily on days 1-7 of each 3-week cycle

  • Docetaxel injectionDrug

    Docetaxel (75mg/m2 IV.drop) will be administered on day 1 of each 3-week cycle, for six cycles.

Study groups in NCT04781686
Study groupRoleWhat they receive
First-line treatmentExperimentalFirst-line treatment: Apatinib plus Camrelizumab combined with Docetaxel and S1 for six cycles. Maintenance treatment: Apatinib and Camrelizumab
Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate; Drug: S1; Drug: Docetaxel injection

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

    Measured: 36 months

Secondary outcomes (4)

  1. objective response rate (ORR)

    Defined as percentage of participants achievingassessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

    Measured: 36 months

  2. overall survival (OS)

    OS is the time from enrollment to death due to any cause.

    Measured: 36 months

  3. disease control rate (DCR)

    DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

    Measured: 36 months

  4. adverse events (AE)

    overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

    Measured: 36 months

Timeline

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

  1. First posted4 Mar 2021
  2. Study start14 May 2021 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781686
Sponsor's protocol ID
HCCSC G05
Status last verified
May 2021
First submitted
1 Mar 2021
Last updated
17 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Apatinib Mesylate and S1 in people with Metastatic Gastric Adenocarcinoma and Metastatic Gastroesophageal Junction Adenocarcinoma, run by Zhou Fuxiang 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 17 May 2021. 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 Fuxiang Zhou, M.D. (+86-027-67813155, happyzhoufx@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 36 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 NCT04781686.

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 17 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in