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Colorectal Cancer RecurrentPhase 1/2NCT04067986

Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer

A Phase 1/2 study testing Camrelizumab and Apatinib in people with Colorectal Cancer Recurrent, run by Zhongshan Hospital Xiamen 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 The sponsor has not verified this record for over two years, so it may be out of date.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 efficacy and safety of the use of Camrelizumab combined with Apatinib Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Recurrent
What is being tested?
Camrelizumab and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
20 Aug 2019to 31 Oct 2021
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 75 years；
  • Patients with histologically or cytologically confirmed advanced or metastatic gastric cancer and colorectal cancer.
  • Patients who had previously progressed after receiving standard second-line advanced treatment；
  • Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 （CT scan length and diameter of tumor lesion≥10mm，CT scan of lymph node lesion was short diameter≥15mm，scan slice thickness 5mm；）
  • ECOG performance status (PS) 0 - 2；
  • Life expectancy of at least 3 months；
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  • Patients with adequate organ function at the time of enrollment as defined below:
  • Blood routine examination standard：（without blood transfusion within 14 days before enrollment）
  • Hb ≥90g/L，
  • WBC≥3.0×109/L
  • ANC ≥ 1.5×109/L，
  • PLT ≥ 80×109/L；
  • Biochemical examination shall meet the following standards：
  • BIL <1.5 times the upper limit of normal（ULN），
  • ALT and aspartate aminotransferase (AST) <2.5×upper limit of normal (ULN)，If liver metastasis is present，ALT and AST<5ULN ；
  • Serum creatinine Cr≤1ULN，Serum creatinine >50ml/min（Cockcroft-Gault math）
  • Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients，and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study； males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period
  • Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

Who cannot join

  • Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years；
  • Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy <2 weeks before enrollment；
  • With severe heart, liver, lung and kidney disease；Significant neurological or psychiatric disorders；Patients with partial or complete gastrointestinal obstruction；
  • Patients with a large amount of pleural effusion or ascites requiring drainage；
  • Patients with symptomatic brain metastasis；
  • Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents; Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment；Patients with acute coronary syndrome（included QTc male>450ms，female>470ms）and cardiac dysfunction；
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  • Women who are pregnant or breastfeeding；
  • Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease;
  • Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease: included HIV positive or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Patients with interstitial lung disease with symptoms or signs of activity；
  • Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion；Coagulation abnormalities （INR>1.5、APTT>1.5ULN）；
  • Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation；
  • Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
  • Patients with a seizure disorder who require pharmacotherapy；
  • Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients；
  • The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
  • participated in other clinical studies before and during treatment；

Trial locations and contacts

1 site in 1 country.

Li Xiao, Doctor contact

2292201 ext. 0592

xiaolibohan@163.com

China1 site, 1 recruiting

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujian, 361000

    Shuntian Cai, +86 18030190632, nktianxingjian@163.com

    Recruiting

Other trials in China

About this study

Official title: Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer：One-arm Exploratory Clinical Trial

The efficacy and safety of the use of Camrelizumab combined with Apatinib

Read the detailed description

To evaluate the clinical efficacy and safety of Camrelizumab combined with Apatinib in the treatment of patients with advanced gastric cancer and colorectal cancer.

The 62 patients were enrolled in a 2-week regimen with 200mg Camrelizumab given intravenously every two weeks and 250mg apatinib mesylate every 4 weeks for a treatment cycle until progressive or intolerable，then the objective remission rate(ORR) was calculated.

Being tested
Camrelizumab, Apatinib

What participants receive

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

  • CamrelizumabDrug

    Also called Apatinib

    Camrelizumab One course will last 28 days.Intravenous injection at a dose of 200 mg, q2w

    One course will last 28 days. Oral administration at a dose of 250 mg/d

  • ApatinibDrug

    Apatinib One course will last 28 days.Oral administration at a dose of 250 mg, qd

Study groups in NCT04067986
Study groupRoleWhat they receive
Camrelizumab + ApatinibOtherCamrelizumab + Apatinib
Receives: Drug: Camrelizumab; Drug: Apatinib

What is being measured

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

  1. 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: one year

Secondary outcomes (1)

  1. Incidence of Treatment-Emergent Adverse-Events

    Incidence of adverse events

    Measured: one year

Timeline

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

  1. First posted28 Aug 2019
  2. Study start20 Aug 2019
  3. Primary completion23 Sep 2020 (estimated)
  4. Study completion31 Oct 2021 (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
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067986
Sponsor's protocol ID
Arise-FJ-R301
Status last verified
Sep 2020
First submitted
14 Aug 2019
Last updated
29 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao L, Gao C, Qiao X, Lou F, Zheng B, Fu M, Huang X, Xie X, Zhang W, Hong Y, Rong K, Shi H, Xiao L, Hu T. Apatinib enhances anti-PD-1 efficacy by inhibiting Exo70-mediated exosome secretion in pMMR/MSS colorectal cancer. NPJ Precis Oncol. 2026 May 30. doi: 10.1038/s41698-026-01518-7. Online ahead of print.

    PubMed 42215704

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Camrelizumab and Apatinib in people with Colorectal Cancer Recurrent, run by Zhongshan Hospital Xiamen 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 18 inclusion and 17 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 29 Sep 2020. 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 Li Xiao, Doctor (2292201 ext. 0592, xiaolibohan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: one year). 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 NCT04067986, 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 29 Sep 2020.

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