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New treatment option for Rectal Cancer
Official title Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
ClinicalTrials.gov ID: NCT06542588
What this study is testing
What is HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)?
HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody) is an investigational medicine, being studied as a potential treatment for rectal cancer.
Also referred to as CAPOX.
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
- The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.
- Phase 2: a mid-size study of how well it works
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
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed Locally Advanced rectal adenocarcinoma
- Genetic test and/or immunohistochemical confirmation of RAS, BRAF wild type
- inferior margin ≤ 10 cm from the anal verge;
You likely can't join if
- Documented history of allergy to study drugs, including any component of Anti-EGFR or PD-1 antibody, capecitabine, oxaliplatin and other platinum...
- Have received or are receiving any of the following treatments: Any radiotherapy, chemotherapy or other anti-tumor drugs for tumor; Patients who need...
- Any active autoimmune disease or history of autoimmune disease;
- Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ...
- There are clinical symptoms or diseases of heart that are not well controlled;
- Severe infection (CTCAE \> 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary...
See the full eligibility criteria
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed Locally Advanced rectal adenocarcinoma
- Genetic test and/or immunohistochemical confirmation of RAS, BRAF wild type
- inferior margin ≤ 10 cm from the anal verge;
- Pelvic MRI shows high risk [meets one of the following conditions]:
- Clinical tumor (cT) staging cT4a or cT4b (according to AJCC 8th Edition)
- Extramural vascular infiltration
- Clinical lymph node (cN) staging cN2 (according to AJCC 8th Edition)
- Mesenteric fascia is involved
- Lateral lymph node enlargement 7 ECOG performance status score is 0-1; 8\. Swallowing pills normally; 9. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc; 10. There...
- Documented history of allergy to study drugs, including any component of Anti-EGFR or PD-1 antibody, capecitabine, oxaliplatin and other platinum drugs;
- Have received or are receiving any of the following treatments: Any radiotherapy, chemotherapy or other anti-tumor drugs for tumor; Patients who need to be treated with corticosteroid (dose equivalent to prednisone of...
- Any active autoimmune disease or history of autoimmune disease;
- Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
- There are clinical symptoms or diseases of heart that are not well controlled;
- Severe infection (CTCAE \> 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the...
- Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within one year before enrollment, or with a history of...
- The presence of active hepatitis B (HBV DNA \> 2000 IU/mL or 104 copies/mL) was positive for hepatitis C (hepatitis C antibody) and HCV RNA was higher than the lower limit of analytical method;
- Female subject who is pregnant or breastfeeding;
- Patients who are not suitable for participation in clinical trials in the opinion of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Hubei, China
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 Wuhan, Hubei, China; Hubei, China. 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.