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AzTrials

Colorectal Cancer MetastaticPhase 2NCT06282445

Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer

A Phase 2 study testing Adebrelimab, Oxaliplatin and Capecitabine in people with Colorectal Cancer Metastatic, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site 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
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Trial summary

To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Adebrelimab, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
1 Mar 2024to 31 Mar 2026
Phase
Phase 2
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

  • 1.The patients voluntarily participated in the study, signed the informed consent, and had good compliance.
  • 2. Age 18-75 years (including 18 and 75) .
  • 3. Metastatic colorectal cancer confirmed histologically and/or cytologically and initially unresectable.
  • 4.MSS or pMMR.
  • 5.Patients must have at least one measurable lesion (RECIST 1.1).
  • 6.ECOG physical condition 0-1 score.
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  • 7.Expected survival ≥12 weeks.
  • 8.Blood examination (no blood transfusion within 14 days, no correction of granulocyte colony stimulating factor or other hematopoietic stimulating factor within 7 days before laboratory examination).
  • neutrophil absolute value ≥1.5×109/L, platelets ≥100×109/L, hemoglobin concentration ≥9g/dL)
  • Liver function test (bilirubin ≤1.5×ULN; Aspartate aminotransferase and glutamic acid aminotransferase ≤2.5×ULN, AST and ALT≤5×ULN in the case of liver metastasis);
  • Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min);
  • Coagulation, International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Thyroid function, thyroid stimulating hormone (TSH) ≤ the upper limit of normal (ULN); If there is any abnormality, FT3 and FT4 levels should be examined. If FT3 and FT4 levels are normal, they can be selected.
  • 9.Reproductive-age women must have a negative serum pregnancy test within 14 days before treatment and be willing to use a medically acceptable effective contraceptive method (e.g., an intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last study dose; for male subjects who are married to a reproductive-age woman, surgical sterilization is required or effective contraception is recommended during the study and for 3 months after the last study dose.

Who cannot join

  • 1.Received the following treatments within 4 weeks prior to treatment: radiotherapy for tumors, surgery, chemotherapy, immunotherapy or molecular targeted therapy, or other investigational medications.
  • 2.Active autoimmune disease requiring systemic therapy (i.e., disease-modifying drugs, corticosteroids, or immunosuppressants) has been used within the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic therapy.
  • 3.Diagnosed with an immune deficiency within 7 days prior to the first treatment or received systemic steroid therapy or any other form of immunosuppressive therapy. The use of physiological doses of corticosteroids may be approved after consultation with the sponsor.
  • 4.Previously received anti-vascular small-molecule targeted drug therapy, such as fuquintinib.
  • 5.Previous treatment with irinotecan based chemotherapy regimens.
  • 6.Symptomatic brain or meningeal metastasis.
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  • 7.RAS wild-type left half colon cancer.
  • 8.Metastatic colorectal cancer with MSI-H or dMMR.
  • 9.Severe infection (such as intravenously administered antibiotics, antifungals, or antivirals) within 4 weeks of treatment, or unexplained fever > 38.5 ° C during screening/first administration.
  • 10.Have high blood pressure that is not well controlled with antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
  • 11.There were obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, black stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc. Or treatment of venous/venous thrombosis events within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic episodes, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required.
  • 12.During screening, it was found that the tumor invaded large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, etc., and the researchers judged that there was a risk of major bleeding.
  • 13.Active heart disease, including myocardial infarction, severe/unstable angina, occurred 6 months before treatment. Left ventricular ejection fraction <50% by echocardiography showed poor arrhythmia control.
  • 14.Patients have had other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within the previous 5 years or at the same time.
  • 15.Is known to be allergic to the investigational drug or any of its excipients.
  • 16.Active or uncontrolled severe infection.
  • Known human immunodeficiency virus (HIV) infection.
  • Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or >2000IU/ml) must be excluded for known hepatitis B virus (HBV) carriers.
  • Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]

Trial locations and contacts

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

Dezhi Li, MD&PhD contact

15268685138

mdlidezhi@163.com

China1 site, 1 recruiting

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    Jinhua, Zhejiang, 322000

    Qijia Xuan, MD&Phd

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study

To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer.

Read the detailed description

At present, the survival benefit of MSS mCRC patients is limited, and the general survival time is only about 3-4 months. Up to now, the standard treatment plan is FOLFOX combined with bevacizumab. AtezoTRIBE study shows that compared with FOLFOXIRI+ bevacizumab, the standard treatment plan is better than the standard treatment plan. The combination of PD-L1 monomone attillizumab extended mPFS from 11.4 months to 12.9 months, showing certain efficacy, and the combination of Attillizumab did not increase adverse reactions. Based on the above, this study aims to explore the efficacy and safety of chemotherapy with XELOX (oxaliplatin + capecitabine) regimen and bevacizumab combined with adbelizumab in first-line treatment of microsatellite stable (MSS) type of initial unresectable metastatic colorectal cancer.

Being tested
Adebrelimab, Oxaliplatin, Capecitabine, Bevacizumab

What participants receive

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

  • AdebrelimabDrug

    Also called SHR-1316

    This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 1200mg, administered every 3 Weeks (Q3W).

  • OxaliplatinDrug

    130 mg/m2, ivgtt, d1, Q3W

  • CapecitabineDrug

    1000mg/m2, po, bid, d1-14, Q3W Maintenance therapy: 1250mg/m2, po, bid, d1-14, Q3W

  • BevacizumabDrug

    7.5mg/kg，ivgtt, d1, Q3W

Study groups in NCT06282445
Study groupRoleWhat they receive
Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With AdebrelimabExperimentalThe enrolled patients with microsatellite stable (MSS) initially unresectable metastatic colorectal cancer will receive a chemotherapy with XELOX and Bevacizumab in combination with Adebrelimab in first-line treatment. XELOX: Oxaliplatin 130 mg/m2, day 1, q3w; Capecitabine 1000 mg/m2, bid, d1-d14, q3w; Bevacizumab: 7.5mg/kg, intravenous infusion, day 1. q3w. Adebrelimab: intravenously guttae, 1200mg, day 1, q3w. 4 cycles. Imaging assessment of tumor remission was performed every 8 weeks. Patients who received 4-6 months of treatment and achieved disease control entered the maintenance treatment stage, receiving maintenance treatment: Bevacizumab: 7.5mg/kg, intravenous infusion, d1, Q3W; Capecitabine: 1250mg/ m2, orally, bid, Q3W; Adebrelimab: 1200mg, intravenous infusion, day 1, Q3W.
Receives: Drug: Adebrelimab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

What is being measured

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

  1. Progression-free survival

    Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Organ retention rate

    The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time limit was the sum of complete and partial responses.

    Measured: Up to 2 years

  2. Overall survival

    The proportion of participants who remain survival at 2 years

    Measured: Up to 2 years

  3. Disease Control Rate

    The percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease.

    Measured: Up to 2 years

  4. Surgical conversion rate

    The rate of conversion to surgery.

    Measured: Up to 2 years

  5. TRAEs

    Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0

    Measured: Up to 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 posted28 Feb 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion31 Mar 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282445
Sponsor's protocol ID
KY-2024-020
Status last verified
Feb 2025
First submitted
21 Feb 2024
Last updated
17 Feb 2025
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 2 study testing Adebrelimab, Oxaliplatin and Capecitabine in people with Colorectal Cancer Metastatic, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site 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 14 inclusion and 19 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Dezhi Li, MD&PhD (15268685138, mdlidezhi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to 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 NCT06282445.

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 Feb 2025.

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