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Advanced Gastric CancerPhase 2NCT04195828

Camrelizumab Combined with Apatinib Mesylate Tablets, Nab-paclitaxel and S-1 in the Treatment of Locally Advanced Gastric Cancer

A Phase 2 study testing Camrelizumab, Apatinib Mesylate and nab-paclitaxel in people with Advanced Gastric Cancer, run by Fujian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate, nab-paclitaxel and S-1 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Camrelizumab, Apatinib Mesylate and nab-paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteChina
Study dates
18 Jun 2020to 24 Mar 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

  • Age: 18-75 years of age
  • Gastric adenocarcinoma was confirmed by pathology（ including histology or cytology）。
  • CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.
  • measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.（CT scan of tumor lesion length≥10mm，CT scan short diameter≥15mm，scan slice thicknes 5mm）
  • ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores;
  • the expected survival time is more than 12 weeks
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  • the main organ function is normal, which should meet the following criteria:
  • blood routine examination standards should be met（no blood transfusion within 14 days）
  • a．HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L （2）biochemical examination shall comply with the following criteria：
  • BIL<1.5 normal upper limit ULN
  • ALT and AST<2.5 ULN,GPT≤1.5×ULN
  • Cr≤1 ULN，CCR（creatinine clearance rate）>60ml/min(Cockcroft-Gault formula)
  • women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test。
  • No other clinical studies were conducted before and during the treatment
  • participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.

Who cannot join

  • Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
  • Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for larger abdominal surgery
  • patients with metastasis
  • Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin
  • A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation
  • Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection
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  • pregnant or lactating women
  • The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg)
  • With Ⅰ magnitude of coronary heart disease, arrhythmia (including QTc protracted between male > 450 ms, women > 470 ms) and cardiac insufficiency
  • Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage；coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;
  • Subjects have failed to control good cardiovascular clinical symptoms or disease, including but not limited to: such as: (1) the NYHA class II heart failure (2) above unstable angina pectoris (3) occurred within 1 year (4) have clinical significance of myocardial infarction (mi) room sex or ventricular arrhythmias without clinical intervention on or after clinical intervention is still poorly controlled
  • History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia
  • Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g);
  • A person who has previously been allergic to any component of camrilizumab or to any component of the drug under study
  • The researchers consider those who were not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

Other trials in China

About this study

Official title: Camrelizumab Combined with Apatinib Mesylate Tablets, Nab-paclitaxel and S-1 in the Treatment of Locally Advanced Gastric Cancer: an Multicenter, Open, Randomized, Controlled Clinical Study

To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate, nab-paclitaxel and S-1

Being tested
Camrelizumab, Apatinib Mesylate, nab-paclitaxel, S1

What participants receive

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

  • CamrelizumabDrug

    Camrelizumab One course will last 21 days.Given once every 3 weeks at a dose of 200 mg.

  • Apatinib MesylateDrug

    Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday。

  • nab-paclitaxelDrug

    nab-paclitaxel One course will last 21 days。Given twice every 3 weeks at a dose of 125 mg/m2.

  • S1Drug

    S-1 was calculated according to body surface area , P.O., bid, d1-d14。And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time

Study groups in NCT04195828
Study groupRoleWhat they receive
Camrelizumab + Apatinib + nab-paclitaxel +S-1ExperimentalCamrelizumab combined with Apatinib mesylate tablets, nab-paclitaxel and S-1 in the treatment of locally advanced gastric cancer
Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate; Drug: nab-paclitaxel; Drug: S1
nab-paclitaxel +S-1Active comparatornab-paclitaxel and S-1 in the treatment of locally advanced gastric cancer
Receives: Drug: nab-paclitaxel; Drug: S1

What is being measured

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

  1. major pathological response

    major pathological response（MPR）

    Measured: 4 months

Secondary outcomes (3)

  1. pathological complete response

    pathological complete response (pCR)

    Measured: 4 months

  2. Objective response rate

    Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

    Measured: 4 months

  3. R0 resection rate

    The surgical procedure was total or subtotal gastrectomy with 3 weeks after total neoadjuvant therapy.

    Measured: 4 months

Timeline

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

  1. First posted12 Dec 2019
  2. Study start18 Jun 2020
  3. Primary completion22 Jul 2022
  4. Study completion24 Mar 2025

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
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04195828
Sponsor's protocol ID
Arise-FJ-G005
Status last verified
Mar 2025
First submitted
10 Dec 2019
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin JX, Tang YH, Zheng HL, Ye K, Cai JC, Cai LS, Lin W, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Zheng CH, Li P, Huang CM. Neoadjuvant camrelizumab and apatinib combined with chemotherapy versus chemotherapy alone for locally advanced gastric cancer: a multicenter randomized phase 2 trial. Nat Commun. 2024 Jan 2;15(1):41. doi: 10.1038/s41467-023-44309-5.

    PubMed 38167806

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Apatinib Mesylate and nab-paclitaxel in people with Advanced Gastric Cancer, run by Fujian 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 15 inclusion and 15 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: finished, as of the sponsor's last update on 1 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

major pathological response (time frame: 4 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 NCT04195828, 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 1 Apr 2025.

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