Locally Advanced Rectal CancerPhase 2NCT07469306
Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
A Phase 2 study testing Modified Short-course radiotherapy, Long-course radiotherapy and Oxaliplatin in people with Locally Advanced 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 plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Modified Short-course radiotherapy, Long-course radiotherapy and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesChina
- Study dates
- 15 Aug 2026to 1 Sep 2027
- Phase
- Phase 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
- 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. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jinluan Li, MD, +86-15959628678, lijinluan@fjmuedu.cn
Chunkang Yang, MD, +86-13509333116, chunk330@163.com
- Not yet recruiting
The Second Hospital of Longyan
Longyan, Fujian, 364000
Ping Lin, +86-139 5909 4969, stone3166@126.com
Hongsheng He
- Not yet recruiting
Jinjiang Municipal Hospital
Quanzhou, Fujian, 362200
Yixiang Zhuang, MD, +86 18876539839
About this study
Official title: Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer
To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.
Read the detailed description
In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Modified Short-course radiotherapy, Long-course radiotherapy, Oxaliplatin, Capecitabine, Tislelizumab
- Keywords
- Modified Short-course radiotherapy (mSCRT), Long-course radiotherapy (LCRT), CAPOX, PD-1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Short-course radiotherapyRadiation
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
Long-course radiotherapyRadiation
Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f
OxaliplatinDrug
130 mg/m²,d1, q3w ,4 cycles
CapecitabineDrug
1000 mg/m, d1-14,bid,q3w, 4 cycles
TislelizumabDrug
200mg,d1,q3w,4 cycles
CapecitabineDrug
825 mg/m² ,BID ,on radiation days
TislelizumabDrug
200mg,d1,q3w,3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab | Experimental | Modified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w *4 cycles.Efficacy and surgery were assessed after the end of treatment. Receives: Radiation: Modified Short-course radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab |
| Long-course radiotherapy Combined with Capecitabine and Tislelizumab | Active comparator | Long-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment. Receives: Radiation: Long-course radiotherapy; Drug: Capecitabine; Drug: Tislelizumab |
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: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.
Secondary outcomes (7)
Organ Preservation Rate
Sphincter-saving rate in enrolled patients
Measured: 1 year.
Surgical Complications
Incidence and severity of postoperative complications.
Measured: Within 30 days post-surgery
the 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: Baseline, before surgery, and up to 12 months after surgery
Grade ≥3 Adverse Event Rate
Incidence of grade 3 or higher adverse events graded according to CTCAE v4.0.
Measured: From start of treatment to 30 days after last dose, up to approximately 6 months
3y-DFS
Proportion of patients without disease recurrence or death from any cause at 3 years.
Measured: From enrollment to 36 month
3y-LRFS
Proportion of patients without local recurrence at 3 years.
Measured: From enrollment to 36 month
3y-OS
Proportion of patients alive at 3 years.
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 posted13 Mar 2026
- Study start15 Aug 2026
- Primary completion10 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jiunluan Li, MD, Principal investigator, Fujian Cancer HospitalChunkang Yang, MD, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469306
- Sponsor's protocol ID
- CATIMOR-2
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2026
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07469306
- Acronym / sponsor ID
- CATIMOR-2
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Modified Short-course radiotherapy (mSCRT), Long-course radiotherapy (LCRT), CAPOX, PD-1 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 13 Mar 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.
To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.
Detailed description
In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab | Experimental | Radiation: Modified Short-course radiotherapy, Drug: Oxaliplatin, Drug: Capecitabine, Drug: TislelizumabModified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w *4 cycles.Efficacy and surgery were assessed after the end of treatment. |
| Long-course radiotherapy Combined with Capecitabine and Tislelizumab | Active comparator | Radiation: Long-course radiotherapy, Drug: Capecitabine, Drug: TislelizumabLong-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed 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 (12 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 |
|---|---|---|
| Modified 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 plus Tislelizumab |
| Long-course radiotherapyRectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f | Radiation | Long-course radiotherapy Combined with Capecitabine and Tislelizumab |
| Oxaliplatin130 mg/m²,d1, q3w ,4 cycles | Drug | Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab |
| Capecitabine1000 mg/m, d1-14,bid,q3w, 4 cycles | Drug | Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab |
| Tislelizumab200mg,d1,q3w,4 cycles | Drug | Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab |
| Capecitabine825 mg/m² ,BID ,on radiation days | Drug | Long-course radiotherapy Combined with Capecitabine and Tislelizumab |
| Tislelizumab200mg,d1,q3w,3 cycles | Drug | Long-course radiotherapy Combined with Capecitabine and Tislelizumab |
Primary outcome
Complete Response (CR) Rate
Time frame: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.
Including pCR and CCR.
7 secondary outcomes
Organ Preservation Rate
Time frame: 1 year.
Surgical Complications
Time frame: Within 30 days post-surgery
the Quality of Life
Time frame: Baseline, before surgery, and up to 12 months after surgery
Grade ≥3 Adverse Event Rate
Time frame: From start of treatment to 30 days after last dose, up to approximately 6 months
3y-DFS
Time frame: From enrollment to 36 month
3y-LRFS
Time frame: From enrollment to 36 month
3y-OS
Time frame: From enrollment to 36 month
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 Oct 2026.
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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.
Jiunluan Li, MD principal investigator
Fujian Cancer Hospital
Chunkang Yang, MD principal investigator
Fujian Cancer Hospital
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 Modified Short-course radiotherapy, Long-course radiotherapy and Oxaliplatin in people with Locally Advanced 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 12 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 Oct 2026. 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?
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 Jinluan Li, MD (15159628678 ext. +86, lijinluan@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.). 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 Oct 2026.