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Gastric CancerPhase 2NCT04294784

Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gastric Cancer

A Phase 2 study testing Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor) and Albumin-bound Paclitaxel in people with Gastric Cancer and GastroEsophageal Cancer, run by Huazhong University of Science and Technology at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer, GastroEsophageal Cancer
What is being tested?
Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor) and Albumin-bound Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
3 Apr 2020to 30 Nov 2023
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 18-70 years.
  • Second line treatment for cytological or histological diagnosis of recurrent or metastatic gastric and esophagogastric adenocarcinoma. Disease progression after adjuvant therapy within 6 months is eligible.
  • ECOG performance status of 0-2.
  • Estimated life expectancy of at least 3 months.
  • Bone marrow function: white blood cell count≥3.0×109 /L, absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L.
  • Left ventricular ejection fraction (LVEF) ≥ 50%.
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  • Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome.
  • Any acute, clinically significant treatment-related toxicity caused by previous treatment must have been reduced to less than or equal to grade 1, except hair loss.
  • Able and willing to comply with the study plans in this protocol and sign the informed consent.

Who cannot join

  • uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
  • Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
  • Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
  • Patients with symptomatic brain metastases.
  • Allergic to the chemotherapy drugs or the materials in this study.
  • Suffering from mental or nervous system disorders and unable to cooperate.
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  • Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
  • Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.
  • Live vaccine was administered within 30 days before enrolment (injectable seasonal influenza vaccine is allowed as it is inactivated).
  • Patients with other diseases not suitable for enrolment, such as active tuberculosis, hepatitis B (after treatment, hepatitis B virus titer HBV-DNA <500IU/ml, and liver function is normal, but cannot be combined with hepatitis C), hepatitis C, uncontrolled electrolyte disorders ,pericardial effusion, pleural effusion and abdominal effusion, etc.
  • Have participated in other clinical trials within 30 days prior to this study.
  • History of organ transplantation.
  • Patients that researcher consider cannot sign informed consent or complete the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: A Multi-center, Open-label, Randomized Controlled Clinical Study of Nab-paclitaxel Plus SHR-1210(PD-1 Inhibitor)Versus Nab-paclitaxel As Second-line Treatment in Advanced or Recurrent Gastric and Esophagogastric Adenocarcinoma

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma

Read the detailed description

This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of an immune checkpoint inhibitor in patients with advanced or recurrent gastric and esophagogastric junction adenocarcinoma, including two arms to compare the efficacy and safety of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）regimen and Albumin-bound Paclitaxel single-agent regimen in second-line treatment.

Being tested
Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor), Albumin-bound Paclitaxel
Keywords
Gastric cancer, GastroEsophageal Cancer, Albumin-bound Paclitaxel, PD-1 inhibitor
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)Drug

    Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;SHR-1210 200mg, ivdrip,d1,Q21d.

  • Albumin-bound PaclitaxelDrug

    Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d,or Albumin-bound Paclitaxel 125-130 mg/m2,ivdrip,d1,d8,Q21d,or Albumin-bound Paclitaxel 260mg/m2,ivdrip,d1,Q21d;

Study groups in NCT04294784
Study groupRoleWhat they receive
Nab-P/PD-1ExperimentalPatients in this arm receive albumin-bound paclitaxel and SHR-1210 (PD-1 inhibitor) thepary.
Receives: Drug: Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)
Nab-PActive comparatorPatients in this arm receive albumin-bound paclitaxel single-agent chemotherapy.
Receives: Drug: Albumin-bound Paclitaxel

What is being measured

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

  1. objective response rate(ORR)

    The rate of participants that achieve either a complete response (CR) or a partial response (PR).Higher rate of ORR indicates better treatment effect.

    Measured: up to 12 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    Time from the start of treatment to progression of disease or death.Higher rate of 9m PFS in statistic analysis means better outcome.

    Measured: up to 9 months

  2. Overall survival (OS)

    Time from the start of treatment until death due to any reason.Increased rate of 12m OS compared to the other arm indicates more benefit from the treatment regimen.

    Measured: up to 12 months

  3. Safety as measured by number and grade of adverse events

    Summary adverse events according to NCI-CTCAE 5.0

    Measured: up to 12 months

  4. patient-reported outcomes (PROs)

    Patient-reported outcomes according to EQ-5D questionnaires.

    Measured: up to 12 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 2020
  2. Study start3 Apr 2020
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Why it stopped: slow recruitment forcing early suspension of screening and enrollment

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294784
Sponsor's protocol ID
TJCC011
Status last verified
Oct 2024
First submitted
2 Mar 2020
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun L, Gong Z, Wang L, Kuang L, Huang Q, Pei B, Yuan X, Qiu H. Multi-center phase II study of nab-paclitaxel plus camrelizumab versus nab-paclitaxel alone as second-line treatment for advanced gastric cancer. Oncologist. 2025 Jul 4;30(7):oyaf189. doi: 10.1093/oncolo/oyaf189.

    PubMed 40554667

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor) and Albumin-bound Paclitaxel in people with Gastric Cancer and GastroEsophageal Cancer, run by Huazhong University of Science and Technology 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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 4 Nov 2024. 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?

The study was stopped early (reason given: slow recruitment forcing early suspension of screening and enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate(ORR) (time frame: up to 12 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 NCT04294784, 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 4 Nov 2024.

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