Rectal CancerPhase 2NCT06542588
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC
A Phase 2 study testing HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody) in people with Rectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesChina
- Study dates
- 19 Jul 2024to Dec 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
- 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]:
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- 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 was no operative contraindication; 11. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 12. Males or females with reproductive ability who are willing to use contraception in the trial;
Who cannot join
- 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 >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Received live attenuated vaccine within 4 weeks before the first use of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- 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;
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- 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 first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
- 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 active pulmonary tuberculosis infection more than one year ago but without regular treatment;
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tao Zhang, MD contact
China3 sites, 3 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei
Zhenyu Lin Lin, MD, 027-85871982, whxhlzy@hust.edu.cn
Zhenyu Lin, MD
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
ZhenYu Lin, 15827130393, tojilin@gmail.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tao Zhang, MD, PHD, 862785871982, 1277577866@qq.com
Zhenyu Lin, MD, 15827130393, tojilin@gmail.com
About this study
Official title: A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer
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.
Read the detailed description
Patients with RAS/BRAF wild type locally advanced rectal cancer (T3-4/N+) , combined risk factors, will be treated with neoadjuvant therapy, and the Primary endpoint of the study is complete response rate(CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) ). PCR assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0). CCR evaluation was based on a combination of digital rectal examination, endoscopy, rectal MRI and blood carcinoembryonic antigen levels.
- Conditions
- Rectal Cancer
- Being tested
- HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)Combination product
Also called CAPOX
Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy | Experimental | Radiotherapy will employ conformal or intensity-modulated radiation therapy, with a pelvic irradiation dose of 25 Gy/5 Fractions/1 week. Then rest for 1 week after radiotherapy and begin to receive neoadjuvant chemotherapy CAPOX, HLX07 and Serplulimab, for 6 cycles.
The patients were operated within 10 weeks after the last treatment, and the surgical method is total mesorectal excision. For patient who achieve CR can choose non-operation management. Receives: Combination Product: HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR) rate
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
Measured: an expected average of 12 months
Secondary outcomes (3)
3-year disease-Free Survival
The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first
Measured: an expected average of 3 years
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Measured: an expected average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start19 Jul 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenyu Lin, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542588
- Sponsor's protocol ID
- HLX10IIT170
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06542588
- Acronym / sponsor ID
- HLX10IIT170
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with RAS/BRAF wild type locally advanced rectal cancer (T3-4/N+) , combined risk factors, will be treated with neoadjuvant therapy, and the Primary endpoint of the study is complete response rate(CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) ). PCR assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0). CCR evaluation was based on a combination of digital rectal examination, endoscopy, rectal MRI and blood carcinoembryonic antigen levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy | Experimental | Combination Product: HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)Radiotherapy will employ conformal or intensity-modulated radiation therapy, with a pelvic irradiation dose of 25 Gy/5 Fractions/1 week. Then rest for 1 week after radiotherapy and begin to receive neoadjuvant chemotherapy CAPOX, HLX07 and Serplulimab, for 6 cycles. The patients were operated within 10 weeks after the last treatment, and the surgical method is total mesorectal excision. For patient who achieve CR can choose non-operation management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (11 listed)
- 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 >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Received live attenuated vaccine within 4 weeks before the first use of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)Also: CAPOXShort course radiotherapy sequential HLX07, Serplulimab and chemotherapy | Combination product | Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy |
Primary outcome
complete response (CR) rate
Time frame: an expected average of 12 months
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
3 secondary outcomes
3-year disease-Free Survival
Time frame: an expected average of 3 years
Overall Survival
Time frame: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time frame: an expected average of 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Zhang, MD contact
Zhenyu Lin, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody) in people with Rectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites 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 12 inclusion and 11 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 zhenyu Lin, MD (027-85871982, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (CR) rate (time frame: an expected average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.