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RECRUITINGPHASE2

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC

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

NCT06542588•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients or their family members agree to participate in the study and sign the informed consent form;
•2. Age 18-75 years, male or female;
•3. Histologically confirmed Locally Advanced rectal adenocarcinoma
•4. Genetic test and/or immunohistochemical confirmation of RAS, BRAF wild type
•5. inferior margin ≤ 10 cm from the anal verge;
•6. 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
+2 more criteria

Exclusion Criteria

•1. Documented history of allergy to study drugs, including any component of Anti-EGFR or PD-1 antibody, capecitabine, oxaliplatin and other platinum drugs;
•2. 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;
•3. Any active autoimmune disease or history of autoimmune disease;
•4. 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;
•5. There are clinical symptoms or diseases of heart that are not well controlled;
•6. 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;
•7. 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;
•8. 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;
•9. Female subject who is pregnant or breastfeeding;
+1 more criteria

Locations (3)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, China

Key Dates

Start Date

July 19, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

December 18, 2024

Enrollment

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

HLX07(anti EGFR antibody) and Serplulimab(anti PD-1 antibody)

COMBINATION_PRODUCT

Contacts

zhenyu Lin, MD

CONTACT

027-85871982 whxhlzy@hust.edu.cn

Tao Zhang, MD

CONTACT

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC

Inclusion Criteria

Exclusion Criteria

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Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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