Evaluating a new treatment for metastatic colorectal cancer
A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab 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)
This study is testing a new treatment combining Serplulimab, Bevacizumab, and chemotherapy to see if it helps people with advanced colorectal cancer feel better and live longer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 568 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Henlius Biotech Industry-sponsored |
| Drugs / interventions | radiation, Serplulimab, Bevacizumab, Chemotherapy |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT04547166 on ClinicalTrials.gov |
What this trial studies
This clinical study is a randomized, double-blinded, multicenter trial designed to assess the efficacy and safety of Serplulimab (HLX10) combined with Bevacizumab (HLX04) and chemotherapy (XELOX) in patients with unresectable metastatic colorectal cancer. The study will enroll approximately 568 patients across multiple countries, including China, Japan, and Indonesia, with a structured approach involving a screening period, treatment cycles lasting up to two years, and follow-up assessments. Participants will be divided into two groups, one receiving the experimental treatment and the other receiving a placebo, to compare outcomes effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with confirmed unresectable metastatic colorectal adenocarcinoma who have not undergone prior systemic anti-tumor treatment.
Not a fit: Patients with resectable metastatic colorectal cancer or those who have previously received systemic anti-tumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic colorectal cancer who have not previously received systemic therapy.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating metastatic colorectal cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria:
1. Histopathologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma
2. Life expectancy ≥ 12 weeks
3. Have not received any previous systemic anti-tumor drug treatment for metastatic colorectal adenocarcinoma
4. For participants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to recurrence or progression must exceed 12 months.
5. 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 radiotherapy can also be regarded as a measurable lesion if PD is confirmed)
6. Agree to provide sufficient previously preserved tumor tissue specimens or agree to undergo biopsy to collect tumor tissue for some gene test.
7. Have an ECOG PS score of 0 or 1 within 7 days prior to receiving the first dose of the study drugs
8. Have Adequate major organ functions.
Key Exclusion Criteria:
1. Have confirmed MSI-H CRC (gene test)
2. Subjects with oligometastatic liver disease and presenting the potential for becoming resectable
3. Presence of central nervous system (CNS) or leptomeningeal metastases
4. 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 more than 30% of the bone marrow area within 28 days prior to randomization is not allowed.
5. 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 of suspected drug-related pulmonary toxicity
6. 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
7. Previously received intestinal stent implantation, with the stent remaining in place at the screening period
8. Uncontrolled hypertension despite clinical treatment (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
9. With a history of hypertensive crisis or hypertensive encephalopathy
10. With a history of significant/severe hemorrhage within 1 month prior to randomization, or have received blood transfusion within 2 weeks prior to randomization
11. 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
12. With evidence showing the presence of meteorism that cannot be attributed to puncture or recent surgery
13. Presence of severe, unhealed or split wounds and active ulcers or untreated fractures
14. Presence of any of the following medical conditions within 6 months prior to randomization:
1. 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)
2. 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, parenteral nutrition, or tube feeding. 2 months prior to randomization, patients with previous symptoms of incomplete obstruction/obstructive syndrome/signs/symptoms of intestinal obstruction that have improved after treatment may be enrolled in the study as assessed by the investigator
3. Severe, uncontrollable intra-abdominal inflammation requiring clinical intervention as judged by the investigator
4. Major vascular disease (e.g., aortic aneurysm requiring surgical repair or associated with recent peripheral artery thrombosis)
Where this trial is running
Guangzhou, Guangdong and 4 other locations
- Center for Cancer Prevention and Treatment of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
- Linyi Cancer Hospital — Linyi, China (Recruiting)
- Fudan University Affiliated Oncology Hospital — Shanghai, China (Recruiting)
- National Cancer Center — Kashiwa, Japan (Not_yet_recruiting)
Study contacts
- Study coordinator: Ruihua Xu
- Email: xurh@sysucc.org.cn
- Phone: 020-87343292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.