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Status unknownNCT04258644Updated Feb 6, 2020

Camrelizumab in Combination With Apatinib Mesylate, Paclitaxel-albumin and S-1 for Translational Treatment of Gastric Cancer

A Phase 2 interventional study of Camrelizumab+Apatinib+Paclitaxel-albumin+S-1 in Gastric Cancer, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Beijing Friendship Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is an interventional clinical trial to assess the efficacy and safety of camrelizumab in combination with apatinib mesylate, paclitaxel-albumin and S-1 for translational treatment of gastric cancer.

02

Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 30 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age:18~70; expected survival>3 months
  2. pathologically diagnosed gastric cancer or esophageal-gastric-junction cancer, being predominantly adenocarcinoma
  3. no previous treatment of anti-cancer drugs
  4. ECOG score 0\~2
  5. CT/MRI/PET-CT diagnosed as unresectable
  6. no disfunction of major organs
  7. lab results satisfy the following criteria:

    • Hb≥90g/L
    • WBC≥3.5×109/L
    • Neutrophil≥1.5×109/L
    • Plt≥100×109/L
    • ALT、AST≤2.5 upper limit (≤5 upper limit for patients with liver metastasis)
    • Tbil≤1.5 upper limit
    • serum creatinine≤1.5 upper limit

7.women at child-bearing age must be tested negative within 7 days before inclusion, and must be willing to take contraception measures during treatment and within 12 weeks after last dose of treatment; men must be sterilized or willing to take contraception measures during treatment and within 12 weeks after last dose of treatment 8.willing to join this research with hand-signed written Informed consent 9.good compliance for follow-up

Exclusion criteria

Exclusion Criteria:

  1. patients with positive HER-2 test
  2. with conditions that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
  3. allergic to carrizumab for injection, apatinib mesylate, paclitaxel for injection (albumin binding type) and tS-1 or relevant drug excipients; allergic to any other monoclonal antibodies; cannot tolerate radiation toxicity;
  4. with active autoimmune disease or autoimmune disease history, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); patients with complete remission of childhood asthma and require no intervention can be included, whereas those who need medical intervention with bronchodilator cannot be included
  5. with congenital or acquired immune defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the lower detection limit of the analysis method) or combined hepatitis B and hepatitis C co infection
  6. immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids for equivalent amount);
  7. inoculated live attenuated vaccine within 4 weeks before the first administration or during the study period
  8. severe infection (requiring intravenous drip of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or fever> 38.5° C of unknown cause during screening / before the first administration
  9. known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  10. objective evidence indicating previous or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, drug-related pneumonia, severe impairment of lung function, etc
  11. patients with hypertension that cannot be restored to the normal range (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg) after treatment with antihypertensive drugs for 3 months
  12. patients with uncontrolled clinical symptoms or diseases of the heart, including but not limited to congestive heart failure (NYHA grade > II); unstable or severe angina; acute myocardial infarction within 6 months; patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; left ventricular ejection fraction (LVEF) \< 50%
  13. patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding > 30 ml within 3 months), hemoptysis (bleeding > 5 ml within 4 weeks), and thromboembolism events (within the past 12 months)
  14. with symptoms indicating Grade 2+ peripheral neuropathy
  15. participating in other clinical trials, or participating in any clinical study for drugs within previous 4 weeks
  16. other situations that the researchers regard as not suitable for inclusion.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Camrelizumab+Apatinib+Paclitaxel-albumin+S-1

    Camrelizumab:D1, 200 mg ivgtt Apatinib Mesylate:D1\~21, 250 mg, po qd Paclitaxel-albumin:D1\&D8, 100~120 mg/m2 S-1:D1\~14, 60mg bid

    Drug: Camrelizumab+Apatinib+Paclitaxel-albumin+S-1

Interventions

  • DrugCamrelizumab+Apatinib+Paclitaxel-albumin+S-1

    Combination therapy of 4 drugs, 21 days for one cycle.

06

What researchers measure

Primary outcomes

  1. R0 resection rate

    proportion of patients for whom radical resection can be achieved

    Time frame: 3 years

Secondary outcomes

  1. ORR

    objective response rate

    Time frame: 3 years

  2. DFS

    disease free survival (period)

    Time frame: 3 years

  3. 3-year DFS

    3-year disease free survival (rate)

    Time frame: 3 years

  4. PFS

    progression free survival (period)

    Time frame: 3 years

  5. OS

    overall survival (period)

    Time frame: 3 years

  6. 1-year OS

    1-year overall survival (rate)

    Time frame: 1 year

  7. 3-year OS

    3-year overall survival (rate)

    Time frame: 3 years

07

Study locations

1 site
  • Beijing Friendship Hospital
    Beijing, Beijing 100050, China
    • Zhongtao Zhang, M.D. · Contact · zhongtao.z@139.com · 8618811792819
    • Kai Pang · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04258644
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhongtao Zhang (Professor, Beijing Friendship Hospital) — Principal investigator
First posted
Feb 6, 2020
Start date
Mar 1, 2020 (estimated)
Primary completion
Feb 28, 2023 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Feb 6, 2020

Study contacts

Zhongtao Zhang
Contact
zhongtao.z@139.com
8618811792819 ext. 8618811792819
Wei Deng
study director · Beijing Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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