Mid-low Rectal CancerPhase 2NCT06333769
Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer
A Phase 2 study testing Short-course Radiotherapy, Tislelizumab and Capecitabine in people with Mid-low Rectal Cancer, run by Fujian Cancer Hospital at 3 sites in China.
Trial summary
To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mid-low Rectal Cancer
- What is being tested?
- Short-course Radiotherapy, Tislelizumab and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesChina
- Study dates
- 12 Jul 2024to 14 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 18-75 years, any gender.
- Pathologically confirmed rectal adenocarcinoma.
- Baseline MR stage T3-4/N+.
- Distance from anal verge ≤12cm.
- No distant metastasis.
- Karnofsky Performance Status ≥70.
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- Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
- Microsatellite/mismatch repair status MSS/pMMR.
- No prior chemotherapy or any other anti-tumor treatment before inclusion.
- No prior immunotherapy.
- Ability to comply with the study protocol during the study period.
- Signed written informed consent.
Who cannot join
- Pregnant or lactating women.
- Pathological diagnosis of signet ring cell carcinoma.
- History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
- Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
- Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
- Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
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- Patients with autoimmune diseases.
- Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
- Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10^9/L; platelets ≥100×10^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.
- Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- Allergy to any investigational drug components.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
The Second Hospital of Longyan
Longyan, Fujian, 364000
Jinjiang Municipal Hospital
Quanzhou, Fujian, 362200
About this study
Official title: A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
Read the detailed description
In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.
- Conditions
- Mid-low Rectal Cancer
- Being tested
- Short-course Radiotherapy, Tislelizumab, Capecitabine, Oxaliplatin
- Keywords
- short-course radiotherapy, CAPOX, PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course RadiotherapyRadiation
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
TislelizumabDrug
Tislelizumab：200mg，d1，q3w，2 cycles.
CapecitabineDrug
Capecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles.
OxaliplatinDrug
Oxaliplatin：130mg/m2, d1, q3w, 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab | Experimental | Modified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment. Receives: Radiation: Short-course Radiotherapy; 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 (CR) rate
Including pCR and CCR.
Measured: From enrollment to 3 month and during follow-up
Secondary outcomes (4)
Organ preservation rate
Sphincter-saving rate in enrolled patients
Measured: 1 year.
Quality of life
EORTC Core Quality of Life questionnaire (QLQ-C30)，range from 0-100, with comprehensive assessment indicators, including positive and negative indicators.
Measured: Before each treatment, before surgery and during follow-up.
3y-DFS
Measured: From enrollment to 36 month
3-year OS
The percentage of patients enrolled who are still alive three years after their initial enrollment.
Measured: From enrollment to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start12 Jul 2024
- Primary completion10 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-low Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333769
- Sponsor's protocol ID
- CATIMOR
- Status last verified
- Aug 2025
- First submitted
- 20 Mar 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
- ClinicalTrials.gov ID
- NCT06333769
- Acronym / sponsor ID
- CATIMOR
- Conditions
- Mid-low Rectal Cancer
- Keywords
- short-course radiotherapy, CAPOX, PD-1 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 27 Mar 2024 (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.
To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
Detailed description
In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab | Experimental | Radiation: Short-course Radiotherapy, Drug: Tislelizumab, Drug: Capecitabine, Drug: OxaliplatinModified SCRT (GTV 30Gy/5f, CTV 22.5Gy/5f), followed by Tislelizumab and CAPOX q3w *2 cycles. Efficacy and surgery were assessed 2-4 weeks after the end of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 years, any gender.
- Pathologically confirmed rectal adenocarcinoma.
- Baseline MR stage T3-4/N+.
- Distance from anal verge ≤12cm.
- No distant metastasis.
Key exclusion criteria (11 listed)
- Pregnant or lactating women.
- Pathological diagnosis of signet ring cell carcinoma.
- History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
- Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
- Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
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 |
|---|---|---|
| Short-course RadiotherapyRectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx. | Radiation | Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab |
| TislelizumabTislelizumab：200mg，d1，q3w，2 cycles. | Drug | Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab |
| CapecitabineCapecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles. | Drug | Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab |
| OxaliplatinOxaliplatin：130mg/m2, d1, q3w, 2 cycles | Drug | Modified Short-course Radiotherapy Combined with CAPOX and Tislelizumab |
Primary outcome
Complete response (CR) rate
Time frame: From enrollment to 3 month and during follow-up
Including pCR and CCR.
4 secondary outcomes
Organ preservation rate
Time frame: 1 year.
Quality of life
Time frame: Before each treatment, before surgery and during follow-up.
3y-DFS
Time frame: From enrollment to 36 month
3-year OS
Time frame: From enrollment to 36 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short-course Radiotherapy, Tislelizumab and Capecitabine in people with Mid-low Rectal Cancer, run by Fujian Cancer Hospital at 3 sites 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: From enrollment to 3 month and during follow-up). 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 15 Aug 2025.