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Gastric CancerPhase 3NCT04714190

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

A Phase 3 study testing RC48-ADC, Paclitaxel injection and Irinotecan Hydrochloride Injection in people with Gastric Cancer and HER2 Overexpressing Gastric Carcinoma, run by RemeGen Co., Ltd. at 52 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RC48-ADC, Paclitaxel injection and Irinotecan Hydrochloride Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
52 sitesChina
Study dates
24 Mar 2021to 30 Jun 2025
Phase
Phase 3
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

  • Voluntary agreement to provide written informed consent.
  • Male or female, Age ≥ 18 years.
  • Predicted survival ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Show all 12Show fewer
  • Adequate organ function.
  • All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma
  • Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
  • The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.
  • HER2 classic positive (definition: IHC3+ or IHC2+FISH+) and patients who have previously failed standard treatment
  • According to the RECIST 1.1 standard, there is at least one measurable lesion.

Who cannot join

  • Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  • History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
  • History of major surgery within 4 weeks of planned start of trial treatment.
  • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Trial locations and contacts

52 sites in 1 country.

Jianmin Fang, PhD contact

010-58075561

jianminfang@hotmail.com

52 sites in 1 country

China52 sites, 52 recruiting

  • Affiliated Hospital of Hebei University

    Baoding

    Aimin Zang

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, 010-53806898, linshenpku@163.com

    Recruiting

  • China-Japan Friendship Hospital

    Beijing

    Liqun Jia

    Recruiting

  • Luhe Hospital Affiliated to Capital Medical University

    Beijing

    Dong Yan

    Recruiting

  • Peking University People's Hospital

    Beijing

    Yingjiang Ye

    Recruiting

  • Jilin Provincial Tumor Hospital

    Changchun

    Ying Cheng

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha

    Shan Zeng

    Recruiting

  • Affiliated Hospital of Chengde Medical College

    Chengde

    Qingshan Li

    Recruiting

  • Three Gorges Hospital Affiliated to Chongqing University

    Chongqing

    Jun Zhang

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Nanfeng Fan

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Dong Ma

    Recruiting

  • Southern Hospital of Southern Medical University

    Guangzhou

    Min Shi

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Shirong Cai

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Yanhong Deng

    Recruiting

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

    Nong Xu

    Recruiting

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

    Fuming Qiu

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Jie'er Ying

    Recruiting

  • The Affiliated Tumor Hospital of Harbin Medical University

    Harbin

    Yuxian Bai

    Recruiting

  • Anhui Cancer Hospital

    Hefei

    Yifu He

    Recruiting

  • Anhui Provincial Hospital

    Hefei

    Yueyin Pan

    Recruiting

  • Jinan Central Hospital

    Jinan

    Meili Sun

    Recruiting

  • Shandong Cancer Hospital

    Jinan

    Changzheng Li

    Recruiting

  • Affiliated Hospital of Jining Medical College

    Jining

    Lei Han

    Recruiting

  • The First People's Hospital of Jining City

    Jining

    Ning Liu

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou

    Hao Chen

    Recruiting

  • Linyi Tumor Hospital

    Linyi

    Zhen Li

    Recruiting

  • Drum Tower Hospital Affiliated to Nanjing University School of Medicine

    Nanjing

    Jia Wei

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing

    Jianwei Lu

    Recruiting

  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

    Nanjing

    Yongqian Shu

    Recruiting

  • Qingdao University Hospital

    Qingdao

    Wensheng Qiu

    Recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

    Jun Zhang

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai

    Xianbao Zhan

    Recruiting

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai

    Tianshu Liu

    Recruiting

  • Cancer Hospital Affiliated to Shantou University Medical College

    Shantou

    Yi Jiang

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang

    Jingdong Zhang

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen

    Ruilian Xu

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Kai Chen

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan

    Mudan Yang

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin

    Yi Ba

    Recruiting

  • Weifang People's Hospital

    Weifang

    Guohua Yu

    Recruiting

  • Weihai Municipal Hospital

    Weihai

    Airong Wang

    Recruiting

  • Huazhong University of Science Tongji Hospital, Tongji Medical College

    Wuhan

    Xianglin Yuan

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Enxiao Li

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Jiayi Li

    Recruiting

  • Affiliated Hospital of Qinghai University

    Xining

    Junhui Zhao

    Recruiting

  • Qinghai Provincial People's Hospital

    Xining

    Yujuan Qi

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang

    Liuzhong Yang

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Chao gao

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Yuan Yuan

    Recruiting

  • Subei People's Hospital of Jiangsu Province

    Yangzhou

    Xizhi Zhang

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai

    Liangming Zhang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Suxia Luo

    Recruiting

Other trials in China

About this study

Official title: Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Gastric Cancer With HER2-overexpression

This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.

Read the detailed description

This study is a phase III multi-center, randomized, open-label, parallel control study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2-overexpression locally advanced or metastatic gastric cancer. The HER2-overexpression is defined as: the HER2 IHC 3+ or 2+, regardless of FISH status.

Being tested
RC48-ADC, Paclitaxel injection, Irinotecan Hydrochloride Injection, Apatinib Mesylate Tablets
Keywords
RC48-ADC, HER2 overexpression, Gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • RC48-ADCDrug

    Also called Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection

    2.5 mg/kg IV every 2 weeks

  • Paclitaxel injectionDrug

    Also called Taxol

    Administered according to label, as one option for Physician's Choice (determined before randomization)

  • Irinotecan Hydrochloride InjectionDrug

    Also called CAMPTO

    Administered according to label, as one option for Physician's Choice (determined before randomization)

  • Apatinib Mesylate TabletsDrug

    Also called Aitan

    Administered according to label, as one option for Physician's Choice (determined before randomization)

Study groups in NCT04714190
Study groupRoleWhat they receive
RC48-ADCExperimentalParticipants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: RC48-ADC
Physician's ChoiceActive comparatorParticipants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
Receives: Drug: Paclitaxel injection; Drug: Irinotecan Hydrochloride Injection; Drug: Apatinib Mesylate Tablets

What is being measured

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

  1. Overall survival (OS)

    Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

    Measured: within approximately 3 years

Secondary outcomes (5)

  1. Progression-free survival (PFS), evaluated by the investigator

    Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

    Measured: within approximately 3 years

  2. Objective remission rate (ORR)

    The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).

    Measured: within approximately 3 years

  3. Duration of relief (DOR)

    DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

    Measured: within approximately 3 years

  4. Disease control rate (DCR)

    Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.

    Measured: within approximately 3 years

  5. Tumor progression time (TTP)

    Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).

    Measured: within approximately 3 years

Timeline

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

  1. First posted19 Jan 2021
  2. Study start24 Mar 2021
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion30 Jun 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714190
Sponsor's protocol ID
RC48-C007
Status last verified
Dec 2023
First submitted
15 Jan 2021
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RC48-ADC, Paclitaxel injection and Irinotecan Hydrochloride Injection in people with Gastric Cancer and HER2 Overexpressing Gastric Carcinoma, run by RemeGen Co., Ltd. at 52 sites 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 12 inclusion and 7 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jianmin Fang, PhD (010-58075561, jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: within approximately 3 years). 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 NCT04714190.

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 21 Dec 2023.

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