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Metastatic Colorectal CancerPhase 2/3NCT04547166

A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)

A Phase 2/3 study testing HLX10 and HLX04、 in people with Metastatic Colorectal Cancer, run by Shanghai Henlius Biotech at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With… 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?
HLX10 and HLX04、
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
568 participants
Where
5 sitesin 2 countries
Study dates
10 Mar 2021to 30 Dec 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Histopathologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma
  • Life expectancy ≥ 12 weeks
  • Have not received any previous systemic anti-tumor drug treatment for metastatic colorectal adenocarcinoma
  • For participants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to recurrence or progression must exceed 12 months.
  • With at least one measurable lesion as assessed by the IRRC per RECIST v1.1, and the measurable lesion should not have been treated locally such as with radiotherapy (a lesion located in an area subjected to previous radiotherapy can also be regarded as a measurable lesion if PD is confirmed)
  • Agree to provide sufficient previously preserved tumor tissue specimens or agree to undergo biopsy to collect tumor tissue for some gene test.
  • Have an ECOG PS score of 0 or 1 within 7 days prior to receiving the first dose of the study drugs
  • Have Adequate major organ functions.

Who cannot join

  • Have confirmed MSI-H CRC (gene test)
  • Subjects with oligometastatic liver disease and presenting the potential for becoming resectable
  • Presence of central nervous system (CNS) or leptomeningeal metastases
  • Have received radiotherapy within 6 months prior to the initiation of study treatment, except for palliative radiotherapy for bone disorders at least 14 days prior to initiation of study treatment; radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not allowed.
  • With a history of or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severe pulmonary dysfunction, or any condition that may interfere with the detection and management of suspected drug-related pulmonary toxicity
  • Have received major surgery within 28 days prior to randomization. A major surgery in this study is defined as a surgery requiring at least 3 weeks of recovery to be able to receive the treatment in this study
Show all 18Show fewer
  • Previously received intestinal stent implantation, with the stent remaining in place at the screening period
  • Uncontrolled hypertension despite clinical treatment (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
  • With a history of hypertensive crisis or hypertensive encephalopathy
  • With a history of significant/severe hemorrhage within 1 month prior to randomization, or have received blood transfusion within 2 weeks prior to randomization
  • Requiring long-term treatment with daily administration of nonsteroidal anti-inflammatory drugs (NSAIDs). Occasional use of NSAIDs to relieve medical symptoms such as headache or pyrexia is allowed
  • With evidence showing the presence of meteorism that cannot be attributed to puncture or recent surgery
  • Presence of severe, unhealed or split wounds and active ulcers or untreated fractures
  • Presence of any of the following medical conditions within 6 months prior to randomization:
  • Abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, massive ascites as judged by the investigator (defined as patients requiring drainage or treatment within two weeks)
  • Intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction associated with a preexisting disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. 2 months prior to randomization, patients with previous symptoms of incomplete obstruction/obstructive syndrome/signs/symptoms of intestinal obstruction that have improved after treatment may be enrolled in the study as assessed by the investigator
  • Severe, uncontrollable intra-abdominal inflammation requiring clinical intervention as judged by the investigator
  • Major vascular disease (e.g., aortic aneurysm requiring surgical repair or associated with recent peripheral artery thrombosis)

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Ruihua Xu contact

020-87343292

xurh@sysucc.org.cn

5 sites in 2 countries

China4 sites, 4 recruiting

  • Center for Cancer Prevention and Treatment of Sun Yat-sen University

    Guangzhou, Guangdong, 510075

    Ruihua Xu, 020-87343292, xurh@sysucc.org.cn

    020-87343292, xurh@sysucc.org.cn

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Haijun Zhong, 0571-87783777

    0571-87783777

    Recruiting

  • Linyi Cancer Hospital

    Linyi

    Qingxu Sun, MD, 0539-8121800

    0539-8121800

    Recruiting

  • Fudan University Affiliated Oncology Hospital

    Shanghai

    junjie peng, 021-64175590, junjiepeng67@163.com

    021-64175590

    Recruiting

Other trials in China

Japan1 site, 1 recruiting

  • National Cancer Center

    Kashiwa

    Takayuki Yoshino, Ph.D, tyoshino@east.ncc.go.jp

    Not yet recruiting

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

Read the detailed description

Patients with confirmed unresectable metastatic/recurrent colorectal adenocarcinoma who have not received systemic anti-neoplastic therapy for metastatic/recurrent lesions will be included in this study.Approximately 6-12 patients will be enrolled in the Part I (Safety Run-in Period).Approximately 100 patients will be enrolled in the Part II (Phase II study, 50 in the test group and 50 in the control group).Approximately 568 patients will be enrolled in the Part III (Phase III study, 284 in the test group and 284 in the control group).

Part II (Phase II study): Approximately 40 study sites in China will participate.

Part III (Phase III study): A total of approximately 75 study sites in 3 countries(including China, Japan, Indonesia) will participate.

The study consists of a screening period (up to 28 days), a treatment period (3-week cycle, up to 2 years), and a follow-up period (including a safety follow-up period, and a survival follow-up every 12 weeks).

Being tested
HLX10, HLX04、
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • HLX10Drug

    Also called serplulimab

    a single fixed dose of 300 mg, intravenous infusion (IV), every 3 weeks (Day 1 of each cycle [D1]), non-reducible.

  • HLX04、Drug

    Also called Bevacizumab

    7.5mg/kg, IV, every 3 weeks (D1 of each cycle), non-reducible.

Study groups in NCT04547166
Study groupRoleWhat they receive
Serplulima +Bevacizumab+XELOXExperimentalSerplulimab (HLX10) in Combination With Bevacizumab and chemotherapy (XELOX)
Receives: Drug: HLX10; Drug: HLX04、
placebo + Bevacizumab+XELOXPlacebo comparatorplacebo in combination with Bevacizumab and chemotherapy (XELOX)
Receives: Drug: HLX04、

What is being measured

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

  1. PFS

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

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes (6)

  1. OS

    Overall survival (OS)

    Measured: From date of randomization until the date of first date of death from any cause, assessed up to 100 months

  2. PFS

    Progression-free survival (assessed by the investigators based on RECIST v1.1)

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  3. ORR

    Objective response rate (assessed by independent radiological review and the investigators based on RECIST v1.1))

    Measured: through study completion, an average of 1 year

  4. Duration of response

    Duration of response

    Measured: 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 up to 2 years

  5. DCR

    Disease control rate

    Measured: the proportion of patients with the best overall response of CR, PR, or stable disease (SD) persisting for 12 weeks

  6. PFS2

    Progression-free survival in the next line of treatment(assessed by the investigators based on RECIST v1.1)

    Measured: From date of randomization until the date of the second documented PD as assessed by the investigator or date of death from any cause, whichever came first, assessed up to 100 months

Timeline

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

  1. First posted14 Sep 2020
  2. Study start10 Mar 2021
  3. Primary completion24 Sep 2025 (estimated)
  4. Study completion30 Dec 2026 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
568 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04547166
Sponsor's protocol ID
HLX10-015-CRC301
Status last verified
Oct 2024
First submitted
7 Sep 2020
Last updated
17 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang ZX, Peng J, Liang X, Cheng Y, Deng Y, Chen K, Zhang M, Zhang J, Wang W, Cao B, Jin Y, Sun M, Lin Y, Luo S, Li Z, Yang L, Ke Y, Yu H, Li J, Wang Q, Zhu J, Wang F, Xu RH. First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. Med. 2024 Sep 13;5(9):1150-1163.e3. doi: 10.1016/j.medj.2024.05.009. Epub 2024 Jun 12.

    PubMed 38870931

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HLX10 and HLX04、 in people with Metastatic Colorectal Cancer, run by Shanghai Henlius Biotech at 5 sites in 2 countries.

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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China, Japan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruihua Xu (020-87343292, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 NCT04547166, 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 17 Oct 2024.

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