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Metastatic Colorectal Cancer (mCRC)Phase 2/3NCT04856787

A Clinical Studyf of SHR-1701 or Placebo in Combination With BP102 and XELOX in the First-line Treatment of mCRC

A Phase 2/3 study testing SHR-1701、 BP102 、XELOX in people with Metastatic Colorectal Cancer (mCRC), run by Suzhou Suncadia Biopharmaceuticals 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 a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer (mCRC)
What is being tested?
SHR-1701、 BP102 、XELOX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteChina
Study dates
22 Jun 2021to 17 Apr 2024
Phase
Phase 2/3
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

  • Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
  • For subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
  • At least 1 measurable lesion according to RECIST V1.1
  • The vital organs are functioning well
  • ECOG score is 0 ~ 1
  • Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

Who cannot join

  • Recurrent or metastatic lesions can be treated with radical surgery
  • Presence of central nervous system or meningeal metastases;
  • Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
  • Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in the case of regular antihypertensive therapy) and prior hypertensive crisis or hypertensive encephalopathy
  • Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlledSubjects with a history of myocardial infarction or unstable angina pectoris
  • Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
  • Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Study of SHR-1701 or Placebo in Combination With BP102 (Biosimilar to Bevacizumab) and XELOX in First-line Treatment of mCRC

This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.

Being tested
SHR-1701、 BP102 、XELOX, placebo、 BP102、 XELOX
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • SHR-1701、 BP102 、XELOXDrug

    Phase 2：Single Group

    Drug:SHR-1701 30mg/kg，IV ,every 3 week

    Drug：BP102 7.5mg/kg，IV,every 3 week

    Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week

    Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

  • SHR-1701、 BP102 、XELOXDrug

    Phase 3：Randomized

    Drug:SHR-1701 30mg/kg，IV ,every 3 week

    Drug：BP102 7.5mg/kg，IV,every 3 week

    Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week

    Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

  • placebo、 BP102、 XELOXDrug

    Phase 3：Randomized

    Drug:Placebo 30mg/kg，IV ,every 3 week

    Drug：BP102 7.5mg/kg，IV,every 3 week

    Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week

    Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

Study groups in NCT04856787
Study groupRoleWhat they receive
SHR-1701 in combination with BP102 and XELOX（Phase 2）ExperimentalNot described
Receives: Drug: SHR-1701、 BP102 、XELOX
SHR-1701 in combination with BP102 and XELOX （Phase 3）ExperimentalNot described
Receives: Drug: SHR-1701、 BP102 、XELOX
placebo in combination with BP102 and XELOXPlacebo comparatorNot described
Receives: Drug: placebo、 BP102、 XELOX

What is being measured

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

  1. Phase 2:ORR

    Objective response rate (assessed by the investigators based on RECIST v1.1)

    Measured: up to 2 years

  2. Phase 2:Incidence of Adverse Events (AEs) by CTCAE v5.0

    Assess safety and tolerability of SHR-1701 in combination with BP102 and XELOX

    Measured: up to 2 years

  3. Phase 3:PFS

    Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)

    Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

Secondary outcomes (4)

  1. DCR

    Disease control rate，the proportion of patients with the best overall response of CR, PR, or stable disease (SD) 。

    Measured: up to 2 years

  2. OS

    Overall survival ，from the date of first dose unitl the date of death from any cause。

    Measured: up to 2 years

  3. PFS

    Progression-free survival from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed (assessed by independent radiological review committee (IRRC) based on iRECIST，by the investigators based on RECIST v1.1))。

    Measured: up to 2 years

  4. Duration of response

    Duration of response，from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed

    Measured: up to 2 years

Timeline

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

  1. First posted23 Apr 2021
  2. Study start22 Jun 2021
  3. Primary completion17 Apr 2024
  4. Study completion17 Apr 2024

Why it stopped: Adjustment of the Company's R\&D Strategy

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856787
Sponsor's protocol ID
SHR-1701-III-301
Status last verified
May 2025
First submitted
19 Apr 2021
Last updated
18 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qiu MZ, Bai Y, Wang J, Gu K, Yang M, He Y, Yi C, Jin Y, Liu B, Wang F, Chen YK, Dai W, Jiang Y, Huang C, Xu RH, Luo HY. Addition of SHR-1701 to first-line capecitabine and oxaliplatin (XELOX) plus bevacizumab for unresectable metastatic colorectal cancer. Signal Transduct Target Ther. 2024 Dec 16;9(1):349. doi: 10.1038/s41392-024-02063-0.

    PubMed 39676137

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SHR-1701、 BP102 、XELOX in people with Metastatic Colorectal Cancer (mCRC), run by Suzhou Suncadia Biopharmaceuticals 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 6 inclusion and 7 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 18 May 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: Adjustment of the Company's R\&D Strategy). 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?

Phase 2:ORR (time frame: up to 2 years). The study lists 3 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 NCT04856787, 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 18 May 2025.

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