New immunotherapy shows promise for Tough-to-Treat colorectal cancer

NCT ID NCT05652894

Disease control Sponsor: Taizhou Hanzhong biomedical co. LTD Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new immunotherapy drug, HX008, against standard chemotherapy for people with a specific type of advanced colorectal cancer (MSI-H/dMMR). The goal is to see if HX008 can delay cancer growth better than chemotherapy. About 190 adults with this genetic marker will be randomly assigned to receive either HX008 or chemotherapy as their first treatment.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily sign the Informed Consent Form（ICF）, understand the study, be willing to follow and be able to complete all test procedures; 2. Male or female, age ≥ 18 years on the day of signing the informed consent form; 3. 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; 4. Confirmed MSI-H/dMMR status by the central laboratory; 5. 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. 6. 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); 7. Eastern Cooperative Oncology Group (ECOG) of 0 or 1; 8. Estimated life expectancy of ≥12 weeks; 9. 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.): 1. Absolute neutrophil count (ANC)≥1.5×10\^9/L 2. White blood cell count (WBC)≥3×10\^9/L 3. Platelet count (PLT)≥100×10\^9/ L 4. Hemoglobin (HGB)≥90 g/L 5. Serum creatinine (Scr) ≤1.5×ULN 6. Alanine aminotransferase (ALT) 、Aspartate aminotransferase (AST) ≤2.5× (upper limit of normal, ULN) . Patients with liver metastases require ALT and AST≤5×ULN, 7. TBIL≤1.5×ULN 8. International normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN;(except for patients on anticoagulant therapy); 10. 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; 11. Participants must have good compliance. Exclusion Criteria: 1. 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.) 2. 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; 3. 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; 4. 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); 5. 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: 1. Locally external use or inhaled corticosteroids; 2. short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of nonautoimmune allergic diseases; 6. Has had prior radiation therapy or has not recovered (≤ Grade 1 or at Baseline) from Adverse events(AEs) due to a previous radiation therapy; 7. 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; 8. Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to randomization; 9. Treatment with investigational products or devices from other clinical trials within 4 weeks prior to randomization; 10. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or found during screening; 11. Has uncontrolled ascites requiring repeated drainage, pleural effusion, or pericardial effusion; 12. Has incomplete intestinal obstruction, active gastrointestinal hemorrhage, or perforation; 13. Has a history or current interstitial pneumonia, or current non--infectious pneumonitis treatment with corticosteroids 14. 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; 15. Subjects with active tuberculosis; 16. History of human immunodeficiency virus infection, acquired or congenital immunodeficiency disease, organ transplantation, or stem cell transplantation; 17. 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; 18. 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 ; 19. Alcohol dependence or drug abuse within the past 1 year; 20. 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; 21. 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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer

Contacts and locations

Locations

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China
Affiliated Qidong Hospital of Nantong University

Nantong, Jiangsu, China
Anhui Provincial Cancer Hospital

Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shangdong, China
Changde First People's Hospital

Changde, Hunan, China
Chengdu Hospital of Integrated Traditional Chinese and Western Medicine

Chengdu, Sichuan, China
China-Japan Union Hospital of Jilin University

Changchun, Jilin, China
Dalian University of Technology Affiliated Central Hospital (Dalian Central Hospital)

Dalian, Shenyang, China
Deyang People's Hospital

Deyang, Sichuan, China
First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China
First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China
Fujian Medical University Union Hospital

Fuzhou, Fujian, China
Gansu Provincial People's Hospital

Lanzhou, Gansu, China
Ganzhou Municipal Hospital

Ganzhou, Jiangxi, China
General Hospital of the Northern Theater Command of the Chinese People's Liberation Army

Shenyang, Liaoning, China
Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China
Guizhou Provincial People's Hospital

Guiyang, Guizhou, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Huai'an First People's Hospital

Huaian, Jiangsu, China
Hubei Cancer Hospital

Wuhan, Hubei, China
Hunan Cancer Hospital

Changsha, Hunan, China
Jiangsu Cancer Hospital

Nanjing, Jiangsu, China
Jiangsu Province Hospital

Nanjing, Jiangsu, China
Liaoning Health Industry Group Fukuang General Hospital

Fushun, Liaoning, China
Meizhou People's Hospital(Huangtang Hospital)

Meizhou, Guangdong, China
Mianyang Central Hospital

Mianyang, Sichuan, China
Nanyang Central Hospital

Nanyang, Henan, China
Ningbo No.2 Hospital

Ningbo, Zhejiang, China
North Sichuan Medical College Affiliated Hospital

Nanchong, Sichuan, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, China
Peking University Cancer Hospital

Beijing, Beijing Municipality, China
Peking University First Hospital

Beijing, Beijing Municipality, China
Qilu Hospital of Shandong University

Jinan, Shangdong, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China
Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Xi'an, China
Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China
Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China
Suzhou Ninth People's Hospotal

Suzhou, Jiangsu, China
The Affiliated Quzhou Hospital of Wenzhou Medical University

Quzhou, Zhejiang, China
The Eighth Affiliated Hospital of Southern Medical University

Foshan, Guangdong, China
The Fifth Affiliated Hospital of Anhui Medical University

Fuyang, Anhui, China
The Fifth People's Hospital Of Datong

Datong, Shanxi, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China
The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China
The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China
The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China
The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Xi'an, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The First Hospital of China Medical University

Shenyang, Liaoning, China
The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The Second People's Hospital of nayang City

Nanchangcun, Henan, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China
Tianjin People's Hospital

Tianjin, Tianjin Municipality, China
Wuhan Central Hospital

Wuhan, Hubei, China
Xuzhou Central Hospital

Xuzhou, Jiangsu, China

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