TQB2930 plus chemo with or without bevacizumab for HER2-abnormally expressed advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study combines TQB2930 with oxaliplatin-capecitabine or irinotecan-capecitabine chemotherapy, with or without bevacizumab, in patients with unresectable locally advanced or metastatic colorectal cancer that overexpresses HER2. It includes phase 1-2 to assess safety and preliminary efficacy. Eligible patients are adults 18-75 with good performance status and measurable disease, confirmed HER2 abnormal expression, and adequate organ function. Exclusion criteria include MSI-H/dMMR tumors and active inflammatory bowel disease. The trial is conducted at multiple Chinese centers with Chia Tai Tianqing as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants voluntarily participate in this study, sign the informed consent form, and have good compliance
* Age: 18-75 years (including the boundary when signing the informed consent form)
* Eastern Cooperative Oncology Group (ECOG) score: 0-1
* Expected survival of more than 3 months
* Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology
* HER2-Abnormally Expressed tested
* Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Participants should agree to use contraception during the study and for 6 months after the end

Exclusion Criteria:

* Participants with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR)
* Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications
* Active inflammatory bowel disease within 28 days prior to first dose
* Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies
* Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy
* Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment
* Had wounds or fractures that had not been healed for a long time
* Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose
* Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders
* Participants with any severe and/or uncontrolled disease
* Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks
* Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study
* Failure to control serous effusions requiring repeated drainage
* Local radiotherapy or 4. Bone marrow irradiation \> 30% for bone metastasis before the first medication
* Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain
* Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication;
* Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment
* History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study;
* Previous history of severe allergy of unknown origin
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the participants' safety or affect the completion of the study, or the participant is considered unsuitable for other reasons

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The Affiliated Hospital of Zunyi Medical University
  Zunyi, Guizhou, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Zhongda Hospital Southeast University
  Nanjing, Jiangsu, China Recruiting
• Liaoning Cancer Hospital & Institute
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: Ruihua Xu, Doctor
• Email: xurh@syscc.org.cn
• Phone: 020-87343468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.