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AzTrials

Colorectal (Colon or Rectal) CancerPhase 2/3NCT07462143

A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer

A Phase 2/3 study testing RC148 (Dose 1) plus Capecitabine and Oxaliplatin and RC148 (Dose 2) plus Capecitabine and Oxaliplatin in people with Colorectal (Colon or Rectal) Cancer, run by RemeGen Co., Ltd. at 19 sites in China.

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 Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal (Colon or Rectal) Cancer
What is being tested?
RC148 (Dose 1) plus Capecitabine and Oxaliplatin and RC148 (Dose 2) plus Capecitabine and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
19 sitesChina
Study dates
12 May 2026to 31 Dec 2030
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

  • Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
  • Aged 18-75 years old (including 18 years old and 75 years old).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Expected survival period ≥ 12 weeks.
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
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  • Subjects must be able to provide tumor tissue samples for biomarker detection.
  • Adequate bone marrow, liver, kidney, and coagulation function.
  • Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.

Who cannot join

  • Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
  • Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
  • Subjects with brain metastases.
  • Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
  • Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
  • Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.
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  • Subjects with acute, chronic, or symptomatic infections.
  • Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
  • Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
  • Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
  • Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
  • Presence of symptomatic or intervention-requiring third-space effusions.
  • Subjects with active or previously diagnosed autoimmune diseases that may recur.
  • History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
  • Subjects who are pregnant, lactating, or planning to become pregnant.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hongfang Li contact

010-65018841

hongfang.li@remegen.com

19 sites in 1 country

China19 sites, 19 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan

    Recruiting

  • Meizhou People's Hospital

    Meizhou, Guangdong

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanjing, Guangxi

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Recruiting

  • The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

    Shijiazhuang, Hebei

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Recruiting

  • People's Hospital of Tianjin

    Tianjin, Tianjin Municipality

    Recruiting

  • Tongji Medical College of Huazhong University of Science &Technology

    Wuhan, Hubei

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer

This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)

Read the detailed description

Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.

Being tested
RC148 (Dose 1) plus Capecitabine and Oxaliplatin, RC148 (Dose 2) plus Capecitabine and Oxaliplatin
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • RC148 (Dose 1) plus Capecitabine and OxaliplatinDrug

    Also called RC148 (Dose 1) plus CAPEOX

    RC148 (Dose 1) plus Capecitabine and Oxaliplatin

  • RC148 (Dose 2) plus Capecitabine and OxaliplatinDrug

    Also called RC148 (Dose 2) plus CAPEOX

    RC148 (Dose 2) plus Capecitabine and Oxaliplatin

Study groups in NCT07462143
Study groupRoleWhat they receive
Experimental Group 1ExperimentalDrug: RC148 （Dose1） in combination with CAPEOX
Receives: Drug: RC148 (Dose 1) plus Capecitabine and Oxaliplatin
Experimental Group 2ExperimentalDrug: RC148 RC148 (Dose 2) in combination with CAPEOX
Receives: Drug: RC148 (Dose 2) plus Capecitabine and Oxaliplatin

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1

    Measured: 24 months

Secondary outcomes (5)

  1. Duration of Response (DoR)

    Duration of Response (DoR) assessed by the investigator according to RECIST v1.1

    Measured: 24 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1

    Measured: 24 months

  3. Time to Response (TTR)

    Time to Response (TTR) assessed by the investigator according to RECIST v1.1

    Measured: 24 months

  4. Overall Survival (OS)

    OS

    Measured: 36 months

  5. AEs/SAE

    The incidence and severity of adverse events / serious adverse events

    Measured: 36 months

Timeline

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

  1. First posted10 Mar 2026
  2. Study start12 May 2026
  3. Primary completion12 May 2027 (estimated)
  4. Study completion31 Dec 2030 (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
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462143
Sponsor's protocol ID
RC148-C303
Status last verified
Feb 2026
First submitted
4 Mar 2026
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing RC148 (Dose 1) plus Capecitabine and Oxaliplatin and RC148 (Dose 2) plus Capecitabine and Oxaliplatin in people with Colorectal (Colon or Rectal) Cancer, run by RemeGen Co., Ltd. at 19 sites 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 9 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites 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 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 Hongfang Li (010-65018841, hongfang.li@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 24 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 NCT07462143.

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 22 May 2026.

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