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Advanced Gastric CancerPhase 1/2NCT04182724

Camrelizumab, Apatinib and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer

A Phase 1/2 study testing Camrelizumab, Apatinib and Nab-paclitaxel in people with Advanced Gastric Cancer, run by Chinese PLA General Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a Phase I/II , Open-label , Investigator-initiated Trail of Camrelizumab (an Anti-PD-1 Inhibitor), Apatinib (VEGFR2 Inhibitor) and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Camrelizumab, Apatinib and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
12 Nov 2019to 12 May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age: more than 18 years old, male or female;
  • 2.Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥ 10mm on spiral computed tomography(CT) scan, satisfying the criteria in Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
  • 3.Failure of prior therapy (during or after treatment) in patients who have received at first line chemotherapy regimens(platinum - based regimens);
  • 4.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;
  • 5.Major organ function has to meet the following criteria: Hemoglobin (HB) ≥ 80g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 90 × 109 / L, ALT and AST ≤ 2.5 × ULN, liver metastases, the ALT and AST≤5 × ULN, Bilirubin ≤ 1.5 times the upper limit of normal (ULN), Serum creatinine ≤ 1.5 times the upper limit of normal (ULN),
  • 6.An expected survival of ≥ 3 months;
  • 7.Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 12 week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 12 week post the last administration of study drug;
  • 8.Patient has to voluntarily join the study and sign the Informed Consent Form for the study.

Who cannot join

  • 1．Other malignancies have been diagnosed within 5 years prior to the first use of the study drug, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or cervical and/or breast cancer in situ which have been effectively treated;
  • 2．Subjects are using immunosuppressive agents.
  • 3．Confirmed that Camrelizumab, Apatinib, Nab-paclitaxel and/or its accessories allergy;
  • 4．Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  • 5．Peripheral neuropathy >1 grade;
  • 6．Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class Ⅰ; Ⅰ-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰ cardiac dysfunction; Patients with positive urinary protein;
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  • 7．Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
  • 8．Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
  • 9．Associated with CNS (central nervous system) metastases;
  • 10．Pregnant or lactating women;
  • 11．With psychotropic drug abuse history and can't get rid of or mental disorder patients;
  • 12．Participated in other clinical trials within 4 weeks;
  • 13．Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
  • 14．Other conditions regimented at investigators' discretion.

Trial locations and contacts

1 site in 1 country.

Guanghai Dai, PhD contact

13801232381

daigh301@vip.sina.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, 100853

    Guanghai Dai, PhD, 13801232381, daigh301@vip.sina.com

    Recruiting

Other trials in China

About this study

This is a Phase I/II , Open-label , Investigator-initiated Trail of Camrelizumab (an Anti-PD-1 Inhibitor), Apatinib (VEGFR2 Inhibitor) and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage.

The first part of the study is the Dose-finding Phase designed to establish the safety of Camrelizumab, Apatinib and Nab-paclitaxel at different dose Levels(125 mg/m2, iv. q2w, 150 mg/m2, iv. q2w, 175 mg/m2, iv. q2w or 200 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses .

This study aims to evaluate the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel in the Second-line treatment of advanced Gastric Cancer.

Read the detailed description

This trial investigated the safety and efficacy of Camrelizumab, Apatinib and Nab-paclitaxel as Second-line Treatment in Advanced Gastric Cancer.

Being tested
Camrelizumab, Apatinib and Nab-paclitaxel

What participants receive

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

  • Camrelizumab, Apatinib and Nab-paclitaxelDrug

    Camrelizumab was administered 200mg iv every 2 weeks, Apatinib was administered 250 mg p.o. qd Nab-paclitaxel was administered 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w

Study groups in NCT04182724
Study groupRoleWhat they receive
Camrelizumab, Apatinib and Nab-paclitaxelExperimentalCamrelizumab was administered 200mg iv every 2 weeks, Apatinib 250 mg p.o. qd Nab-paclitaxel 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w
Receives: Drug: Camrelizumab, Apatinib and Nab-paclitaxel

What is being measured

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

  1. MTD /DLT (phase I)

    Maximum Tolerated Dose/Dose Limiting Toxicity

    Measured: Within four weeks after administration

  2. ORR(phase II)

    Overall Response Rate

    Measured: from the first drug administration up to two years

Secondary outcomes (2)

  1. Incidence of Treatment-Emergent Adverse Events (phase I/II)

    adverse events/serious adverse events

    Measured: from the first drug administration to within 90 days for the last drug dose

  2. PFS(phase I/II)

    Progression-Free-Survival

    Measured: from the first drug administration up to two years

Timeline

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

  1. First posted2 Dec 2019
  2. Study start12 Nov 2019
  3. Primary completion12 May 2021 (estimated)
  4. Study completion12 May 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
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04182724
Sponsor's protocol ID
Camrelizumab GC
Status last verified
Dec 2019
First submitted
27 Nov 2019
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gou M, Zhang Y, Wang Z, Qian N, Dai G. PD-1 inhibitor combined with albumin paclitaxel and apatinib as second-line treatment for patients with metastatic gastric cancer: a single-center, single-arm, phase II study. Invest New Drugs. 2024 Apr;42(2):171-178. doi: 10.1007/s10637-024-01425-3. Epub 2024 Feb 12.

    PubMed 38347177

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Camrelizumab, Apatinib and Nab-paclitaxel in people with Advanced Gastric Cancer, run by Chinese PLA General Hospital 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 8 inclusion and 14 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 3 Dec 2019. 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 Guanghai Dai, PhD (13801232381, daigh301@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD /DLT (phase I) (time frame: Within four weeks after administration). The study lists 2 primary outcomes in all. 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 NCT04182724, which also lists 1 linked publication.

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 3 Dec 2019.

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