Rectal CancerPhase 1/2TNTITNCT07561060
Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy
A Phase 1/2 study testing Tislelizumab, Capecitabine and Oxaliplatin in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, then underwent clinical response assessment. 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?
- Tislelizumab, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to Mar 2028
- Phase
- Phase 1/2
- 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
- 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 tumor is within 3 cm of the dentate line. through colonoscopy, digital anal examination or MRI
- clinical stage cT1-3 N 0-1M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)
Show all 11Show fewer
- 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.
Who cannot join
- Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
- Have received any treatments for rectal cancer, or evidence of distant metastasis
- Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
- Presence or in high risk of obstruction, perforation or bleeding;
- Not suitable for long-course radiotherapy
- Cannot tolerate surgery
Show all 14Show fewer
- ≥2 colorectal cancer lesions at the same time
- Contraindications for MRI examination
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital, Shanghai
Shanghai, Shanghai Municipality, 200032
Jianmin Xu, MD, 13501984869, xujmin@aliyun.com
Wenju Chang, MD, 13764476150, chang_erich@hotmail.com
About this study
Official title: A Single-arm, Multicenter, Phase II Clinical Study of Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy in Resectable Low Rectal Cancer
This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, 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).
- Conditions
- Rectal Cancer
- Being tested
- Tislelizumab, Capecitabine, Oxaliplatin
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
200 mg IV on Day 1 of each 21-day cycle.
CapecitabineDrug
Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
OxaliplatinDrug
130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
CapecitabineDrug
825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| tislelizumab | Experimental | All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, 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). Receives: Drug: Tislelizumab; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response rate (CR rate)
defined as the proportion of participants with clinical complete response(cCR) or near clinical complete response (ncCR) who achieved local resection confirmed pCR determined by the investigators after 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy.
Measured: From first dose up to 12 months, approximately
Secondary outcomes (4)
1/2/3 year organ-preservation rate
defined as the proportion of participants who survived and did not underwent TME in 1/2/3 year (in the CR set and full analysis set respectively)
Measured: From first dose of radiotherapy up to 36 months, approximately
1/2/3 year EFS rate
defined as the proportion of participants who did not develop local recurrence, distant metastasis, new invasive primary lesions of colorectal cancer, or death in 1/2/3 year (in the CR set, non-CR set and full analysis set respectively)
Measured: From first dose of radiotherapy up to 36 months, approximately
1/2/3 year OS rate
defined as the proportion of participants who survived in 1/2/3 year (in the full analysis set)
Measured: From first dose of radiotherapy up to 36 months, approximately
Percentage of Participants With Adverse Events
Percentage of Participants With adverse events (AEs) , immune-related adverse events(irAE) and serious adverse events (SAEs) per the National Cancer Institute CommonTerminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Measured: From first dose of radiotherapy up to 36 months, approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (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 Fudan UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561060
- Sponsor's protocol ID
- TNTIT
- Acronym
- TNTIT
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Phase II Clinical Study of Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy in Resectable Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT07561060
- Acronym / sponsor ID
- TNTIT / TNTIT
- Conditions
- Rectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 May 2026 (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.
This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tislelizumab | Experimental | Drug: Tislelizumab, Drug: Capecitabine, Drug: OxaliplatinAll patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 tumor is within 3 cm of the dentate line. through colonoscopy, digital anal examination or MRI
Key exclusion criteria (14 listed)
- Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
- Have received any treatments for rectal cancer, or evidence of distant metastasis
- Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
- Presence or in high risk of obstruction, perforation or bleeding;
- Not suitable for long-course radiotherapy
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 |
|---|---|---|
| Tislelizumab200 mg IV on Day 1 of each 21-day cycle. | Drug | tislelizumab |
| CapecitabineCapecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen | Drug | tislelizumab |
| Oxaliplatin130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen | Drug | tislelizumab |
| Capecitabine825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy. | Drug | tislelizumab |
Primary outcome
Complete Response rate (CR rate)
Time frame: From first dose up to 12 months, approximately
defined as the proportion of participants with clinical complete response(cCR) or near clinical complete response (ncCR) who achieved local resection confirmed pCR determined by the investigators after 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy.
4 secondary outcomes
1/2/3 year organ-preservation rate
Time frame: From first dose of radiotherapy up to 36 months, approximately
1/2/3 year EFS rate
Time frame: From first dose of radiotherapy up to 36 months, approximately
1/2/3 year OS rate
Time frame: From first dose of radiotherapy up to 36 months, approximately
Percentage of Participants With Adverse Events
Time frame: From first dose of radiotherapy up to 36 months, approximately
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 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tislelizumab, Capecitabine and Oxaliplatin in people with Rectal Cancer, run by Fudan University at 1 site 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 11 inclusion and 14 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jianmin Xu, MD (+862164041990, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response rate (CR rate) (time frame: From first dose up to 12 months, approximately). 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 1 May 2026.