Gastric CancerPhase 2NCT04934618

A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment for Advanced Gastric Cancer

A Phase 2 study testing Carelizumab Combined With Irinotecan and Apatinib in people with Gastric Cancer, run by Nanfang Hospital, Southern Medical 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study was to evaluate the overall survival time (OS), objective remission rate（ORR）, progression-free survival time（PFS）, disease control rate（DCR）of Carelizumab combined with irinotecan and apatinib for the second-line treatment of locally advanced unresectable, recurrent or metastatic… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer
What is being tested?: Carelizumab Combined With Irinotecan and Apatinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteChina
Study dates: 19 May 2020to 19 May 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

The local advanced stage confirmed by histopathology is unresectable, recurrent or metastatic Adenocarcinoma of stomach and gastroesophageal junction.
After receiving first-line treatment, the disease progressed or intolerable adverse reactions occurred.
At least one measurable lesion or evaluable lesion (according to RECIST 1.1 standard);
Patients agreed to provide blood samples and previously stored tumor tissue samples for tumor microenvironment detection.
Age ≥18 years old and ≤75 years old.
The ECOG score is 0 or 1.

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The estimated survival time is ≥3 months.
Within 7 days before entering the group, the laboratory test value met the chemotherapy standard.
Within 28 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to adopt effective contraceptive measures during the study drug use and within 6 months after the last administration.
Patients voluntarily joined the study, signed informed consent, and were able to comply with the visit and related procedures stipulated in the plan.

Who cannot join

Participate in other intervention clinical studies at the same time (unless participating in observation studies or being in the follow-up stage of intervention studies), and have received second-line treatment.
have received antibody therapy of PD-1, PD-L1, PD-L2, CTLA4, CD137 or any other antibody or drug therapy with t cell co-stimulation or immune checkpoint pathway as specific target.
It is known to be allergic to any monoclonal antibody or adjuvant.
Received Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration.
Having undergone major surgery within 4 weeks before the first administration or expecting to undergo surgery during the study treatment.
Receive live attenuated vaccine within 4 weeks before the first administration or during the planned study treatment.

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Received transplantation of solid organs or blood system.
Active, known or suspected autoimmune diseases or related medical history in the past 2 years (vitiligo, psoriasis, alopecia or Graves' disease that does not require systematic treatment in the past 2 years, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes patients who only need insulin replacement therapy can enter Group).
Immunosuppressive drugs have been used within 4 weeks before the first administration, excluding local glucocorticoid by nasal spray, inhalation or other routes or systemic glucocorticoid with physiological dose (i.e., prednisone or other glucocorticoid with equivalent dose not exceeding 10mg/ day), or hormone used due to allergy.
Known history of primary immunodeficiency disease.
Known history of active tuberculosis. 12 known to have a history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
13. after regular antihypertensive treatment, the blood pressure still cannot fall to the normal range (systolic blood pressure > >140mmHg, diastolic blood pressure > >90mmHg).
14. ≥II grade ii coronary heart disease and arrhythmia (including QTc interval prolongation > >450ms for men and > >470ms for women).
15. Symptomatic congestive heart failure (new york Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia.
16. before the first administration, there was toxicity caused by previous anti-tumor treatment that did not recover to grade 0 or grade 1 of the national cancer institute general adverse event terminology version 4.03 (NCI ctcae version 4.03) (excluding alopecia, fatigue and asymptomatic laboratory abnormalities).
17. abnormal coagulation function (INR > 1.5 uln, aptt > 1.5 uln), with bleeding tendency.
18. It is known that symptomatic central nervous system metastasis exists. 19. Diagnosed as other malignant tumors within 5 years before the first administration, excluding basal cell carcinoma of skin, squamous cell carcinoma of skin and carcinoma in situ after radical resection.
20. Active infections requiring treatment or systemic anti-infective drugs used within 7 days before the first administration.
21. acute or chronic active hepatitis b: HBV viral load ≥500 copies /ml 22. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the study.
23. It is known that there are mental diseases or drug abuse situations that may affect the compliance with the test requirements.
24. Acute or chronic active hepatitis C: HCV antibody is positive. 25. Pregnant or lactating women. 26. There are medical histories, diseases, treatments or abnormal laboratory results that may interfere with the test results and prevent the subjects from participating in the study, or the researchers think that participating in the study is not in the best interests of the subjects.

Trial locations and contacts

1 site in 1 country.

Min Shi contact

Chunlin Wang contact

China1 site, 1 recruiting

NanFang Hospital
Guangzhou, Guangdong, 510515
Min Shi, 020-62787736, nfyyshimin@163.com
Chunlin Wang, 020-62787735, wangchunl03@163.com
Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Open-labeled, Phase II Study on the Efficacy and Safety of Carelizumab Combined With Irinotecan and Apatinib in the Second-line Treatment of Locally Advanced Unresectable, Recurrent or Metastatic Adenocarcinoma of Stomach and Gastroesophageal Junction

Conditions: Gastric Cancer
Being tested: Carelizumab Combined With Irinotecan and Apatinib
Medical subject headings: Stomach Neoplasms

What participants receive

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

Carelizumab Combined With Irinotecan and ApatinibDrug
Three-drug regimen was used in second-line treatment of Advanced gastric cancer

Study groups in NCT04934618
Study group	Role	What they receive
Carelizumab Combined With Irinotecan and Apatinib	Experimental	Second-line treatment of advanced gastric cancer with three-drug regimen（Carelizumab Combined With Irinotecan and Apatinib ） Receives: Drug: Carelizumab Combined With Irinotecan and Apatinib

What is being measured

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

Overall Suvival time（OS）
The time from randomization to death due to any reason. For those who have lost follow-up before death, the last follow-up time is usually calculated as the time of death.
Measured: Up to 24 months

Secondary outcomes (4)

Progress Free Survival time（PFS）
The time from randomization to the first occurrence of disease progression or death from any cause.
Measured: Up to 24 months
objective response rate（ORR）
Refers to the proportion of patients whose tumors have shrunk to a certain amount and kept for a certain time, including CR and PR cases
Measured: Up to 24 months
duration of response （DoR）
It is the curative effect evaluation index of tumor reaction, which refers to the time from the first evaluation of complete remission (CR) or partial remission (PR) to the first evaluation of disease progression (PD) or death from any cause
Measured: Up to 24 months
Disease control rate（DCR）
The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of complete remission (CR), partial remission (PR) and stable (SD)
Measured: Up to 24 months

Timeline

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

19 May 202019 May 2025

First posted22 Jun 2021
Study start19 May 2020
Primary completion19 May 2023 (estimated)
Study completion19 May 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 85 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04934618
Sponsor's protocol ID: NFEC-2020-024
Status last verified: Jun 2021
First submitted: 12 Jun 2021
Last updated: 22 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Multicenter, Open-labeled, Phase II Study on the Efficacy and Safety of Carelizumab Combined With Irinotecan and Apatinib in the Second-line Treatment of Locally Advanced Unresectable, Recurrent or Metastatic Adenocarcinoma of Stomach and Gastroesophageal Junction
ClinicalTrials.gov ID: NCT04934618
Acronym / sponsor ID: NFEC-2020-024
Conditions: Gastric Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 85 participants (estimated)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Study start: 19 May 2020 (actual)
Primary completion: 19 May 2023 (estimated)
Study completion: 19 May 2025 (estimated)
First posted: 22 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Carelizumab Combined With Irinotecan and Apatinib	Experimental	Drug: Carelizumab Combined With Irinotecan and ApatinibSecond-line treatment of advanced gastric cancer with three-drug regimen（Carelizumab Combined With Irinotecan and Apatinib ）

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The local advanced stage confirmed by histopathology is unresectable, recurrent or metastatic Adenocarcinoma of stomach and gastroesophageal junction.
After receiving first-line treatment, the disease progressed or intolerable adverse reactions occurred.
At least one measurable lesion or evaluable lesion (according to RECIST 1.1 standard);
Patients agreed to provide blood samples and previously stored tumor tissue samples for tumor microenvironment detection.
Age ≥18 years old and ≤75 years old.

Key exclusion criteria (21 listed)

Participate in other intervention clinical studies at the same time (unless participating in observation studies or being in the follow-up stage of intervention studies), and have received second-line treatment.
have received antibody therapy of PD-1, PD-L1, PD-L2, CTLA4, CD137 or any other antibody or drug therapy with t cell co-stimulation or immune checkpoint pathway as specific target.
It is known to be allergic to any monoclonal antibody or adjuvant.
Received Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration.
Having undergone major surgery within 4 weeks before the first administration or expecting to undergo surgery during the study treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carelizumab Combined With Irinotecan and ApatinibThree-drug regimen was used in second-line treatment of Advanced gastric cancer	Drug	Carelizumab Combined With Irinotecan and Apatinib

Primary outcome

Overall Suvival time（OS）
Time frame: Up to 24 months
The time from randomization to death due to any reason. For those who have lost follow-up before death, the last follow-up time is usually calculated as the time of death.

4 secondary outcomes

Progress Free Survival time（PFS）
Time frame: Up to 24 months
objective response rate（ORR）
Time frame: Up to 24 months
duration of response （DoR）
Time frame: Up to 24 months
Disease control rate（DCR）
Time frame: Up to 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Min Shi contact

Chunlin Wang contact

Min Shi principal investigator

Oncology department of Nanfang hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carelizumab Combined With Irinotecan and Apatinib in people with Gastric Cancer, run by Nanfang Hospital, Southern Medical 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 10 inclusion and 21 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 22 Jun 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 Min Shi (020-62787736, nfyyshimin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Suvival time（OS） (time frame: Up to 24 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 NCT04934618.

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 22 Jun 2021.