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Metastatic Colorectal CancerPhase 2NCT03645876

SHR-1210 in Combination With BP102 and XELOX in Patient With Metastatic Colorectal Cancer

A Phase 2 study testing SHR-1210, BP102 and oxaliplatin in people with Metastatic Colorectal Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 an open label, single-arm, multi-center, phase II study of SHR-1210 in metastatic colorectal cancer patients with the recurrent lesion(s) post-surgery or the untreated mCRC. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1).BP102 is a humanized recombinant monoclonal IgG1 antibody. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
SHR-1210, BP102 and oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
8 Nov 2018to 18 Apr 2019
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 and ≤75 years old;
  • Histologically confirmed colorectal cancer with a metastatic / recurrent lesion that cannot be cured by surgery.
  • At least one measurable lesion have been the confirmatory detection respect to RECIST 1.1
  • No prior first-line systemic anti-tumor therapy for mCRC (including systemic chemotherapy, molecular targeted therapy, biotherapy, immunotherapy, radiotherapy, local therapy and other study treatment) have been identified
  • At least 6 months have elapsed if considering the interval from the time of firstly documented metastasis to the post-operational adjuvant chemotherapy termination
  • Can provide either a newly obtained or archival tumor tissue sample.
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy ≥ 3 months
  • Subjects must have normal organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) ≥1,500 /mm3（1.5×109 /L）
  • Platelets ≥90,000 / mm3（90×109 /L）
  • Hemoglobin ≥10 g/dL, within the 2 weeks prior to the screening no need for the transfusion
  • Serum albumin ≥2.8 g/dL
  • Total bilirubin≤ 1.5 X ULN, AST (SGOT), ALT (SGPT) ≤ 2.5 X ULN (AST/ALT ≤ 5 X ULN if liver metastatic);
  • Creatinine clearance ≥ 50 mL/min according to Cockcroft-Gault formula
  • For females of child bearing potential, a negative urine or serum pregnancy test result within 72h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study until 3 months after the last dose of any of the drugs in the study.
  • The subjects are accredited with good compliance, signed the informed consent, and capable to cooperate, completing the relevant examination and follow-ups.

Who cannot join

  • Prior first-line systemic anti-tumor therapy for mCRC (including systemic chemotherapy, molecular targeted therapy, immunotherapy, biotherapy, and other treatment).
  • The metastatic/recurrent lesion is subject to be cured by surgical intervention.
  • Major operation or open biopsy or major trauma within 4 weeks prior to first dose.
  • Known Cerebral and/or leptomeningeal metastasis.
  • Bleeding predisposition, high bleeding risk or coagulant disorder, thrombotic event(s) occurrence ≤6 months and/or hemoptysis ≤3 months (≥ 1/2 teaspoons fresh blood each) prior to the screening; use of full dose oral or parenteral anticoagulant or thrombolytic medication (allowing preventative anticoagulation); use of aspirin (> 325 mg/day) or other platelet-inhibition non-steroidal anti-inflammatory drugs within 10 days since the screening; CT/MRI imaging evidence, testimony of the main arteries/veins (such as pulmonary artery or superior vena cava) being infringed, encroached
  • Subjects with uncontrolled hypertension and with a medical history of hypertensive crisis or hypertensive encephalopathy; serious cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA) ≤6 months before the screening, transient ischemic attack (TIA), myocardial infarction and significant vascular disease (including but not limited to aortic aneurysms with need for surgical repair or recent evidence of arterial thrombosis), unstable angina, heart failure and serious arrhythmias that are uncontrolled by drugs (New York Heart Association Class ≥2).
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  • Subjects with non-healing wounds, active peptic ulcer or fracture and active infection; tracheal esophageal fistula, gastrointestinal perforation or gastrointestinal fistula and abdominal abscess in the 6 months prior to the screening.
  • Subjects with any active autoimmune disease or history of autoimmune disease
  • Active infection or an unexplained fever > 38.5°C before two weeks of randomization (subjects with tumor fever may be enrolled at the discretion of the investigator);
  • History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
  • Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
  • Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 or BP102 formulation, allergy, hypersensitivity, or contraindication to oxaliplatin, or Capecitabine
  • Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
  • Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers
  • Received a live vaccine within 4 weeks of the first dose of study medication
  • Pregnancy or breast feeding.
  • According to the investigator, other conditions that may lead to stop the research.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center of Sun-Yat Sen University (CCSYSU)

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: SHR-1210，a Novel Anti-pd-1 Antibody, in Combination With BP102,a Biosimilar of Bevacizumab, and XELOX, (Oxaliplatin Plus Capecitabine) in Patient With Metastatic Colorectal Cancer: a Single-arm, Open Label, Multi-center, Phase II Study

This is an open label, single-arm, multi-center, phase II study of SHR-1210 in metastatic colorectal cancer patients with the recurrent lesion(s) post-surgery or the untreated mCRC.

SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1).BP102 is a humanized recombinant monoclonal IgG1 antibody.

The primary objective of this study is to investigate the safety and efficacy of the subjects who given the combination therapy.

Being tested
SHR-1210, BP102, oxaliplatin, capecitabine
Keywords
SHR-1210, BP102, Phase II
Medical subject headings
Colorectal Neoplasms

What participants receive

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

Study groups in NCT03645876
Study groupRoleWhat they receive
SHR-1210+BP102+XELOXExperimentalParticipants receive SHR-1210 200mg,BP102 7.5mg/kg and oxaliplatin 130mg/m2 in day 1 intravenously every 3week, capecitabine by oral bid in day1-14 every 3 week until disease progression or unacceptable toxicity
Receives: Drug: SHR-1210; Drug: BP102; Drug: oxaliplatin; Drug: capecitabine

What is being measured

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

  1. Safety of the combination therapy: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    From sign icf to the end of follow-up

    Measured: 24 months

  2. Objective response rate

    From sign icf to occurrence of objective response (complete regression (CR) and partial regression (PR) need to be confirmed 28 days after the occurrence)

    Measured: 24 months

Secondary outcomes (5)

  1. DOR

    Duration of response ,DOR

    Measured: 24 months

  2. DCR

    Disease Control Rate，DCR

    Measured: 24 months

  3. PFS

    Progression free survival,PFS

    Measured: 24 months

  4. 9month PFS rate

    Month 9 PFS rate,PFS9m

    Measured: 9 months

  5. 12month and 24 month OS rate

    Overall survival rate: the time from the date of icf to the date of documented clinical or radiological progression or death due to any cause within 12 and 24 months after first visit

    Measured: 24 months

Timeline

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

  1. First posted24 Aug 2018
  2. Study start8 Nov 2018
  3. Primary completion18 Apr 2019
  4. Study completion18 Apr 2019

Why it stopped: The study was terminated early due to company decision

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645876
Sponsor's protocol ID
SHR-1210-II-210
Status last verified
May 2019
First submitted
20 Aug 2018
Last updated
10 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210, BP102 and oxaliplatin in people with Metastatic Colorectal Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 17 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: stopped early, as of the sponsor's last update on 10 May 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 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: The study was terminated early due to company decision). 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?

Safety of the combination therapy: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: 24 months). 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 NCT03645876.

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 10 May 2019.

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