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New treatment option for Locally Advanced Rectal Cancer (LARC)
Official title Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study
ClinicalTrials.gov ID: NCT07020247
What this study is testing
What is Anti-PD-1 antibody drug named Serplulimab?
Anti-PD-1 antibody drug named Serplulimab is an investigational medicine, being studied as a potential treatment for locally advanced rectal cancer (larc).
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, randomized controlled, phase III 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) sustained for over one year) of patients with locally advanced rectal cancer(LARC) treated with personalized long-course radiotherapy plus chemotherapy with or without Serplulimab. A total of 184 patients were included in this study.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: ≥18 years old; sex is not limited.
- Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a and invasion of...
- The lower edge of lesion is less than 10cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.
- No distant metastasis after a thorough examination .
- Pathological diagnosis of rectal adenocarcinoma,and Immunohistochemistry and/or genetic testing for MSS/pMMR;
You likely can't join if
- Patients who have previously received pelvic radiotherapy.
- Presence of active or progressive infection requiring systemic treatment, such as active tuberculosis, active hepatitis, etc.
- Presence of systemic diseases that are not stably controlled by the investigator, including diabetes mellitus, hypertension, liver cirrhosis...
- Have had prior or concurrent cancer distinct in primary site or histology (including synchronous colon cancer) , except for curatively treated...
- Has any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator...
- Estimated inadequate patient compliance to participate in this clinical study.
See the full eligibility criteria
- Age: ≥18 years old; sex is not limited.
- Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a and invasion of intestinal lumen for more than 1/2 week (measured by...
- The lower edge of lesion is less than 10cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.
- No distant metastasis after a thorough examination .
- Pathological diagnosis of rectal adenocarcinoma,and Immunohistochemistry and/or genetic testing for MSS/pMMR;
- ECOG score: 0-1.
- Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy.
- The main organ function is normal, including the following characteristics: ①Blood routine examination: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L，NE≥ 1.5×109/L，PLT≥ 100×109/L ②Biochemical examination：Crea and BIL ≤ 1.0 upper...
- Not allergic to 5-Fu or Platinum.
- The site of radiotherapy had not previously received radiation.
- If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use...
- Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up.
- Patients who have previously received pelvic radiotherapy.
- Presence of active or progressive infection requiring systemic treatment, such as active tuberculosis, active hepatitis, etc.
- Presence of systemic diseases that are not stably controlled by the investigator, including diabetes mellitus, hypertension, liver cirrhosis, rheumatic immune diseases, and severe lung diseases.
- Have had prior or concurrent cancer distinct in primary site or histology (including synchronous colon cancer) , except for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.
- Has any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition for...
- Estimated inadequate patient compliance to participate in this clinical study.
- History of gastrointestinal fistula, perforation, bleeding or severe ulceration or presence of severe gastrointestinal disease that affects the absorption of oral chemotherapy drugs.
- Patients who have received solid organ transplantation or bone marrow transplantation, or have had active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, 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.