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Metastatic Colorectal CancerPhase 3NCT05652894

A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

A Phase 3 study testing HX008(Pucotenlimab) and Investigator's Choice Chemotherapy in people with Metastatic Colorectal Cancer, run by Taizhou Hanzhong biomedical co. LTD at 63 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
HX008(Pucotenlimab) and Investigator's Choice Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
63 sitesChina
Study dates
28 Feb 2023to 20 Oct 2028
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the Informed Consent Form（ICF）, understand the study, be willing to follow and be able to complete all test procedures;
  • Male or female, age ≥ 18 years on the day of signing the informed consent form;
  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum, classified as Stage IV according to the AJCC (8th edition, 2017) TNM staging system for colorectal cancer;
  • Confirmed MSI-H/dMMR status by the central laboratory;
  • No prior systemic treatment for metastatic colorectal cancer; subjects received neoadjuvant/adjuvant therapy with disease progression should be completed > 6 months prior to the neoadjuvant/adjuvant therapy were enrolled.
  • Has at least one measurable extracranial lesion (Lesions with the longest diameter ≥ 10mm, or lymph nodes with a short diameter ≥ 15mm) according to Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1), which has not been treated with local treatment(Lesions located in the area of previous radiation therapy can also optional if the progression is confirmed);
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  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1;
  • Estimated life expectancy of ≥12 weeks;
  • Adequate organ and hematopoietic function (no blood transfusion within 14 days prior to hematology tests, and no use of any hematopoietic growth factors or/and thrombopoietic agents within 7 days), based on the following laboratory tests (retesting is allowed only once during the screening period. If the retest results meet the inclusion criteria, the baseline values will be based on the retest results.):
  • Absolute neutrophil count (ANC)≥1.5×10^9/L
  • White blood cell count (WBC)≥3×10^9/L
  • Platelet count (PLT)≥100×10^9/ L
  • Hemoglobin (HGB)≥90 g/L
  • Serum creatinine (Scr) ≤1.5×ULN
  • Alanine aminotransferase (ALT) 、Aspartate aminotransferase (AST) ≤2.5× (upper limit of normal, ULN) . Patients with liver metastases require ALT and AST≤5×ULN,
  • TBIL≤1.5×ULN
  • International normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN;(except for patients on anticoagulant therapy);
  • Women of childbearing age must have a negative pregnancy test within 72 hours before the first dose of trial treatment. Reproductive men and women of childbearing age are willing to take adequate contraceptive measures (such as oral contraceptives, intrauterine contraceptives, sexual abstinence, or barrier contraceptives combined with spermicide) from signing the informed consent form to 12 months after the last administration of the trial drug;
  • Participants must have good compliance.

Who cannot join

  • Prior systemic treatment for metastatic colorectal cancer (subjects who received neoadjuvant/adjuvant therapy with disease progression should be completed > 6 months prior to the neoadjuvant/adjuvant therapy were enrolled.)
  • Subjects diagnosed with any other malignancy within 5 years prior to randomization, except for malignancies with a low risk of metastasis and death (5-year survival rate > 90%), such as adequately basal cell or squamous cell skin cancer or carcinoma in situ of the cervix and other carcinomas in situ;
  • Had prior treatment with any anti-PD-1, anti-PD-L1, PD-L2, or CTLA-4 agent or any other drug targeting T cell co-stimulation or immune checkpoint pathway;
  • Has active autoimmune disease (except for psoriasis), that has required systemic treatment in the past 2 years((eg, corticosteroids or immunosuppressive drugs). Except for alternative therapies (eg, thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency);
  • Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible:
  • Locally external use or inhaled corticosteroids;
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  • short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of nonautoimmune allergic diseases;
  • Has had prior radiation therapy or has not recovered (≤ Grade 1 or at Baseline) from Adverse events(AEs) due to a previous radiation therapy;
  • Has received a significant surgery, open biopsy, or severe trauma within 4 weeks prior to randomization; Definition of major surgery: the minimum of 3 weeks of post-operative recovery time is required to undergo this study, any wound-related AE must be resolved prior to randomization;
  • Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to randomization;
  • Treatment with investigational products or devices from other clinical trials within 4 weeks prior to randomization;
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or found during screening;
  • Has uncontrolled ascites requiring repeated drainage, pleural effusion, or pericardial effusion;
  • Has incomplete intestinal obstruction, active gastrointestinal hemorrhage, or perforation;
  • Has a history or current interstitial pneumonia, or current non--infectious pneumonitis treatment with corticosteroids
  • Participants with inadequately controlled cardiovascular diseases judged by the investigator as unsuitable for participation in this trial, including but not limited to: (1) NYHA Class II or above cardiac function, (2) Angina unstable;
  • Subjects with active tuberculosis;
  • History of human immunodeficiency virus infection, acquired or congenital immunodeficiency disease, organ transplantation, or stem cell transplantation;
  • Active chronic hepatitis B or active hepatitis C. Except for hepatitis B virus carriers or those with stable disease after drug treatment, and participants with HBV DNA titer ≤ 500 IU/mL or < 2500 copies/mL are eligible. Active hepatitis C is defined as known positive hepatitis C antibody with known hepatitis C RNA quantitative results above the lower limit of detection of the analytical method;
  • Known to be allergic to macromolecular protein agents or monoclonal antibodies. Known to have a history of severe allergies to any of the chemotherapy drugs in the study ;
  • Alcohol dependence or drug abuse within the past 1 year;
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment. Subjects are permitted to receive inactivated vaccines including those for seasonal influenza, intranasal influenza vaccines are not allowed;
  • Presence of other serious physical or mental illness or abnormal laboratory tests that may increase the risk of subjects in the study, or interfere with the study results, and the researchers believe that patients who are not suitable to participate in the trial for other reasons.

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

China63 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • Changde First People's Hospital

    Changde, Hunan

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Chengdu Hospital of Integrated Traditional Chinese and Western Medicine

    Chengdu, Sichuan

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan

  • Dalian University of Technology Affiliated Central Hospital (Dalian Central Hospital)

    Dalian, Shenyang

  • The Fifth People's Hospital Of Datong

    Datong, Shanxi

  • Deyang People's Hospital

    Deyang, Sichuan

  • The Eighth Affiliated Hospital of Southern Medical University

    Foshan, Guangdong

  • Liaoning Health Industry Group Fukuang General Hospital

    Fushun, Liaoning

  • The Fifth Affiliated Hospital of Anhui Medical University

    Fuyang, Anhui

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi

  • Ganzhou Municipal Hospital

    Ganzhou, Jiangxi

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

  • Huai'an First People's Hospital

    Huaian, Jiangsu

  • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

    Jinan, Shangdong

  • Qilu Hospital of Shandong University

    Jinan, Shangdong

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Meizhou People's Hospital(Huangtang Hospital)

    Meizhou, Guangdong

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second People's Hospital of nayang City

    Nanchangcun, Henan

  • North Sichuan Medical College Affiliated Hospital

    Nanchong, Sichuan

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi

  • Affiliated Qidong Hospital of Nantong University

    Nantong, Jiangsu

  • Nanyang Central Hospital

    Nanyang, Henan

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang

  • The Affiliated Quzhou Hospital of Wenzhou Medical University

    Quzhou, Zhejiang

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

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

    Shanghai, Shanghai Municipality

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong

  • General Hospital of the Northern Theater Command of the Chinese People's Liberation Army

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Suzhou Ninth People's Hospotal

    Suzhou, Jiangsu

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Wuhan Central Hospital

    Wuhan, Hubei

  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Xi'an

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Xi'an

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized Phase III Study of HX008 (a Humanized Monoclonal Antibody Against PD-1) Compared to Investigator's Choice Chemotherapy in the First-Line Treatment of Subjects With Microsatellite Instability-High (MSI-H)/Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC).

Being tested
HX008(Pucotenlimab), Investigator's Choice Chemotherapy
Keywords
Colorectal Neoplasms Intestinal Neoplasms Bevacizumab Cetuximab Irinotecan Oxaliplatin Antibodies Antibodies Monoclonal Antine
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • HX008(Pucotenlimab)Drug

    Drug: HX008(Pucotenlimab) 200 mg ,Q3W

  • Investigator's Choice ChemotherapyDrug

    Drug: bevacizumab 5mg/kg given by IV every 14 days. Other Name: Avastin

    Drug: cetuximab 400 mg/m2 for the first dose, then 250 mg/sqm, intravenous infusion, repeated weekly; or Cetuximab 500 mg/ sqm, intravenous infusion, D1, repeated every 2 weeks.

    Other Name: Erbitux

    Drug: oxaliplatin 85 mg/sqm by IV, day1. Component of mFOLFOX6.

    Drug: irinotecan 180 mg/sqm by IV, day1.Component of FOLFORI.

    Drug: calcium Folinate 400 mg/sqm by IV, day1.Component of mFOLFOX6 or FOLFORI.

    Drug: 5-fluorouracil 400 mg/sqm, day1,followed by 2400 mg/sqm iv infusion over 46~48 h.Component of mFOLFOX6 or FOLFORI.

    Drug: oxaliplatin 130 mg/sqm, intravenous infusion over 2 h ± 30 min, Day 1. Component of CAPEOX.

    Drug: capecitabine 1000 mg/sqm administered orally twice daily, Days 1-14. Component of CAPEOX.

    Drug: bevacizumab 7.5 mg/kg, intravenous infusion, D1, repeated every 3 weeks

Study groups in NCT05652894
Study groupRoleWhat they receive
HX008(Pucotenlimab)ExperimentalSubjects receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W)
Receives: Drug: HX008(Pucotenlimab)
Investigator's Choice ChemotherapyActive comparator1. mFOLFOX6 2. mFOLFOX6+Bevacizumab 3. mFOLFOX6+Cetuximab 4. FOLFORI 5. FOLFORI+Bevacizumab 6. FOLFORI+Cetuximab 7. CAPEOX 8. CAPEOX+ Bevacizumab
Receives: Drug: Investigator's Choice Chemotherapy

What is being measured

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

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Independent Review Committee(IRC)

    PFS, defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by IRC or death due to any cause, whichever occurs first.

    Measured: 2 years

Secondary outcomes (19)

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigators

    PFS, defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

    Measured: 2 years

  2. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by IRC or investigators

    ORR, defined as the percentage of subjects achieving complete response (CR) and partial response (PR).

    Measured: 2 years

  3. Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by IRC or investigators

    DCR, defined as the proportion of subjects achieving CR, PR, and Stable disease(SD) after treatment.

    Measured: 2 years

  4. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by IRC or investigators

    DOR, defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

    Measured: 2 years

  5. Overall Survival (OS)

    OS, defined as the duration from the start of treatment to death of any cause.

    Measured: 2 years

  6. Immune Progression-free Survival (iPFS)-Experimental group per iRECIST assessed by IRC/investigators

    iPFS, defined as the time from randomization to the first documented disease immune progression per iRECIST assessed by IRC/investigators or death due to any cause, whichever occurs first.

    Measured: 2 years

  7. Immune Objective Response Rate (iORR)-Experimental group per iRECIST assessed by IRC/investigators

    iORR, defined as the proportion of subjects with a best overall response (BOR) of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IRC/investigators.

    Measured: 2 years

  8. Immune Disease Control Rate (iDCR) -Experimental group per iRECIST assessed by IRC/investigators

    response, a partial response or stable disease according to immune Response Evaluation Criteria In Solid Tumors (iRECIST) criteria by IRC/investigators over the the total number of evaluable patients.

    Measured: 2 years

  9. Immune Duration of Response (iDOR)-Experimental group per iRECIST assessed by IRC/investigators

    iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IRC/investigators.

    Measured: 2 years

  10. Objective tumor response rate 2 (ORR2) (crossover phase) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigators

    ORR2, defined as proportion of subjects with best overall response of CR or PR, in progressors who continue to receive HX008 in crossover group.

    Measured: 2 years

  11. Disease Control Rate 2 (DCR 2) (crossover phase) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigators

    DCR2, defined as the proportion of subjects achieving CR, PR, and SD after treatment who continue to receive HX008 in crossover group.

    Measured: 2 years

  12. Duration of Response 2 (DOR2) (crossover phase) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigators

    DOR2, defined as the duration from the initial recording received HX008 in crossover group of objective disease response to the second onset of tumor progression, or death of any cause.

    Measured: 2 years

  13. Progression-free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors

    PFS2, defined as duration of time until 2nd confirmed objective disease progression or death (or last documentation of being alive).

    Measured: 2 years

  14. Immune Objective Response Rate 2 (iORR2) (crossover phase) per iRECIST assessed by investigators

    iORR2, defined as the proportion of subjects with a best overall response (BOR) of immune complete response (iCR) or immune partial response (iPR) in progressors who continue to receive HX008 in crossover group based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by investigators.

    Measured: 2 years

  15. Immune Disease Control Rate 2 (iDCR2) (crossover phase) per iRECIST assessed by investigators

    iDCR 2, defined as the percentage of patients whose best overall response is either a complete response, a partial response or stable disease who continue to receive HX008 in crossover group according to immune Response Evaluation Criteria In Solid Tumors (iRECIST) criteria by investigators over the the total number of evaluable patients.

    Measured: 2 years

  16. Immune Duration of Response 2 (iDOR2) (crossover phase) per iRECIST assessed by investigators

    iDOR2, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) who continue to receive HX008 in crossover group based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by investigators.

    Measured: 2 years

  17. Immune Progression-free Survival 2 (iPFS2) (crossover phase) per iRECIST assessed by investigators

    iPFS2, defined as duration of time until 2nd confirmed objective disease progression or death (or last documentation of being alive) who continue to receive HX008 in crossover group based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by investigators.

    Measured: 2 years

  18. Safety: AEs, laboratory test parameters, etc.

    Measured: 2 years

  19. Quality of life assessment

    Measured: 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 posted15 Dec 2022
  2. Study start28 Feb 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion20 Oct 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652894
Sponsor's protocol ID
HX008-III-CRC-01
Status last verified
May 2026
First submitted
26 Nov 2022
Last updated
14 May 2026
Results posted
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 3 study testing HX008(Pucotenlimab) and Investigator's Choice Chemotherapy in people with Metastatic Colorectal Cancer, run by Taizhou Hanzhong biomedical co. LTD at 63 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 19 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 14 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 63 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 phase mean?

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?

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?

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Independent Review Committee(IRC) (time frame: 2 years). 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 NCT05652894.

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 14 May 2026.

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