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Tests treatment safety and results for Metastatic Colorectal Cancer
Official title A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
ClinicalTrials.gov ID: NCT04547166
What this study is testing
What is HLX10?
HLX10 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as serplulimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histopathologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma
- Life expectancy ≥ 12 weeks
- Have not received any previous systemic anti-tumor drug treatment for metastatic colorectal adenocarcinoma
- For participants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to recurrence or progression must exceed...
- With at least one measurable lesion as assessed by the IRRC per RECIST v1.1, and the measurable lesion should not have been treated locally such as...
You likely can't join if
- Have confirmed MSI-H CRC (gene test)
- people with oligometastatic liver disease and presenting the potential for becoming resectable
- Presence of central nervous system (CNS) or leptomeningeal metastases
- Have received radiotherapy within 6 months prior to the initiation of study treatment, except for palliative radiotherapy for bone disorders at least...
- With a history of or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severe pulmonary dysfunction...
- Have received major surgery within 28 days prior to randomization. A major surgery in this study is defined as a surgery requiring at least 3 weeks...
See the full eligibility criteria
- Histopathologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma
- Life expectancy ≥ 12 weeks
- Have not received any previous systemic anti-tumor drug treatment for metastatic colorectal adenocarcinoma
- For participants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to recurrence or progression must exceed 12 months.
- With at least one measurable lesion as assessed by the IRRC per RECIST v1.1, and the measurable lesion should not have been treated locally such as with radiotherapy (a lesion located in an area subjected to previous...
- Agree to provide sufficient previously preserved tumor tissue specimens or agree to undergo biopsy to collect tumor tissue for some gene test.
- Have an ECOG PS score of 0 or 1 within 7 days prior to receiving the first dose of the study drugs
- Have Adequate major organ functions. Key
- Have confirmed MSI-H CRC (gene test)
- people with oligometastatic liver disease and presenting the potential for becoming resectable
- Presence of central nervous system (CNS) or leptomeningeal metastases
- Have received radiotherapy within 6 months prior to the initiation of study treatment, except for palliative radiotherapy for bone disorders at least 14 days prior to initiation of study treatment; radiotherapy covering...
- With a history of or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severe pulmonary dysfunction, or any condition that may interfere with the detection and management...
- Have received major surgery within 28 days prior to randomization. A major surgery in this study is defined as a surgery requiring at least 3 weeks of recovery to be able to receive the treatment in this study
- Previously received intestinal stent implantation, with the stent remaining in place at the screening period
- Uncontrolled hypertension despite clinical treatment (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
- With a history of hypertensive crisis or hypertensive encephalopathy
- With a history of significant/severe hemorrhage within 1 month prior to randomization, or have received blood transfusion within 2 weeks prior to randomization
- Requiring long-term treatment with daily administration of nonsteroidal anti-inflammatory drugs (NSAIDs). Occasional use of NSAIDs to relieve medical symptoms such as headache or pyrexia is allowed
- With evidence showing the presence of meteorism that cannot be attributed to puncture or recent surgery
- Presence of severe, unhealed or split wounds and active ulcers or untreated fractures
- Presence of any of the following medical conditions within 6 months prior to randomization:
- Abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, massive ascites as judged by the investigator (defined as patients requiring drainage or treatment within two weeks)
- Intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction associated with a preexisting disease or requiring routine parenteral hydration...
- Severe, uncontrollable intra-abdominal inflammation requiring clinical intervention as judged by the investigator
- Major vascular disease (e.g., aortic aneurysm requiring surgical repair or associated with recent peripheral artery thrombosis)
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Hangzhou, Zhejiang, China
- Linyi, China
- Shanghai, China
- Kashiwa, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Hangzhou, Zhejiang, China; Linyi, China; Shanghai, China; Kashiwa, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.