NCT06390982Not yet recruitingPhase 2
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer：the RELIEVE-01 Study
Source: ClinicalTrials.gov · Last updated 30 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 26 Apr 2024
- Start date
- May 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT06390982
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From May 2024 to the primary completion date, Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received any treatments for rectal cancer, or evidence of distant metastasis
- Not suitable for long-course radiotherapy
- Cannot tolerate surgery
Other illness
- Presence or in high risk of obstruction, perforation or bleeding;
- ≥2 colorectal cancer lesions at the same time
- Other malignant tumors in the past or at the same time
- Have an active autoimmune disease requiring systemic therapy within the past 2 years
- HIV infection
- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \> 500 IU/mL) or active HCV carriers with detectable HCV RNA;
- Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container
- Other conditions judged by the researcher that do not meet the enrollment requirements
Other
- Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
- Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
- Contraindications for MRI examination
Who the study is looking for
- Able to provide written informed consent, understand and comply with the requirements and evaluation schedule
- ≥18, ≤75 years old
- Histologically confirmed rectal adenocarcinoma
- immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS
- The distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or MRI
- clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)
- Resectable primary tumor assessed by the Investigator
- Have not received any anti-tumor treatment for rectal cancer
- ECOG PS ≤ 1
- Adequate organ function
- Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.