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New treatment option for Rectal Cancer
Official title The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer
ClinicalTrials.gov ID: NCT06254521
What this study is testing
What is Tislelizumab combined with chemotherapy?
Tislelizumab combined with chemotherapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for rectal cancer.
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
- This study aims to elucidate the effects of neoadjuvant Tislelizumab combined with chemotherapy in locally advanced MSS rectal cancer.
- 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 and older
You may be able to join if
- Age ≥18 years old and ≤70 years old.
- Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by...
- The lower edge of the tumor is less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS.
- It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT.
- The ECOG physical status score is 0-1.
You likely can't join if
- Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is...
- Multifocal colorectal cancer.
- Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement.
- Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.
- History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.
- Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute...
See the full eligibility criteria
- Age ≥18 years old and ≤70 years old.
- Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.
- The lower edge of the tumor is less than 12cm from the anus as measured by colonoscopy and MRI,or TRUS.
- It was confirmed by magnetic resonance imaging (MRI) or intracavitary ultrasound of the rectum as T3-4 or N+, and M0 by enhanced CT.
- The ECOG physical status score is 0-1.
- Life expectancy is expected to be more than 1 year.
- First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.
- Appropriate organ function is defined as follows: Hemoglobin level ≥ 90g/L, Neutrophil count ≥ 1.5×10\^9/L, Platelet count ≥ 75×10\^9/L, Serum total bilirubin ≤ 1.5× the upper limit of normal (UNL), Aspartate...
- Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.
- Early rectal cancer (T1-2N0M0); The lower margin of the tumor was less than 5cm from the anus and T4. APR(combined abdominal perineal resection) is required;
- Multifocal colorectal cancer.
- Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement.
- Cannot tolerate chemotherapy or immunotherapy, such as but not limited to bone marrow suppression.
- History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.
- Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia...
- Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.
- Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.
- Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form, or having comorbidities requiring the use of glucocorticoid therapy.
- Unable to undergo enhanced CT examination
- Pregnancy or lactation.
- Refused to participate in this study.
- Other situations in which the researcher deems unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, Guangxi, 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 Nanning, Guangxi, 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.