Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal CancerPhase 2NCT07448077
Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC
A Phase 2 study testing Experimental: short-course radiotherapy and immunotherapy and Chemoradiotherapy in people with Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer
- What is being tested?
- Experimental: short-course radiotherapy and immunotherapy and Chemoradiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.age >=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .
- 4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: <10 cm from the anal verge. 6.Adequate organ function:
- Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L.
- Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)
- Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- 7. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.
- 8. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.
Who cannot join
- Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.
- Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.
- Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.
- Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization.
- Significant cardiovascular disease, such as myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, or hypertension that remains uncontrolled above 160/100 mmHg despite optimal therapy.
- History of other malignant tumors, excluding non-melanoma skin cancer and cervical carcinoma in situ that have been curatively treated and disease-free for ≥ 5 years.
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- Uncontrolled diabetes (HbA1c > 8%) or thyroid dysfunction requiring medication for abnormal TSH.
- Severe chronic intestinal conditions，including but not limited to Crohn's disease or active ulcerative colitis.
- The investigators believe that patients were inappropriate for participation.
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
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Fengpeng Wu, Professor, 15032818011
About this study
Official title: Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
- Being tested
- Experimental: short-course radiotherapy and immunotherapy, Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: short-course radiotherapy and immunotherapyDrug
patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Enlonstobart 200mg IV every 3 weeks; Oxaliplatin 130mg/m2 IV Q3W d1 Capecitabine 1000mg/m2 bid d1-14 q3w
ChemoradiotherapyDrug
Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| short-course radiotherapy and immunotherapy | Experimental | patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Receives: Drug: Experimental: short-course radiotherapy and immunotherapy |
| chemoradiotherapy | Active comparator | Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy Receives: Drug: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response Rate (pCR+cCR )
Clinical complete response or pathological complete response (cCR or pCR)
Measured: up to 2 year
Secondary outcomes (5)
Major pathologic response rate
Measured: up to 2 year
R0 resection rate
Measured: The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3-year event-free survival (EFS) rate
Measured: up to 3 years
3-year overall survival (OS)
Measured: up to 3 years
Adverse Event
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2026
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengpeng WU, MD, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448077
- Sponsor's protocol ID
- CSPC-ESX-CRC-K01
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2026
- Last updated
- 31 Jul 2026
- Results posted
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07448077
- Acronym / sponsor ID
- CSPC-ESX-CRC-K01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 4 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.
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-course radiotherapy and immunotherapy | Experimental | Drug: Experimental: short-course radiotherapy and immunotherapypatients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart |
| chemoradiotherapy | Active comparator | Drug: ChemoradiotherapyLong-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.age >=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .
- 4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: <10 cm from the anal verge. 6.Adequate organ function:
- 7. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment.
- 8. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments.
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| Experimental: short-course radiotherapy and immunotherapypatients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Enlonstobart 200mg IV every 3 weeks; Oxaliplatin 130mg/m2 IV Q3W d1 Capecitabine 1000mg/m2 bid d1-14 q3w | Drug | short-course radiotherapy and immunotherapy |
| ChemoradiotherapyLong-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy | Drug | chemoradiotherapy |
Primary outcome
complete response Rate (pCR+cCR )
Time frame: up to 2 year
Clinical complete response or pathological complete response (cCR or pCR)
5 secondary outcomes
Major pathologic response rate
Time frame: up to 2 year
R0 resection rate
Time frame: The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3-year event-free survival (EFS) rate
Time frame: up to 3 years
3-year overall survival (OS)
Time frame: up to 3 years
Adverse Event
Time frame: up to 2 year
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 31 Jul 2026.
- Individual participant dataSharing planned: No
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 2 study testing Experimental: short-course radiotherapy and immunotherapy and Chemoradiotherapy in people with Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer, run by Hebei Medical University Fourth Hospital 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 7 inclusion and 9 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 31 Jul 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 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 Linlin Xiao, Dr (18533167355, drxiaolinlin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response Rate (pCR+cCR ) (time frame: up to 2 year). 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 31 Jul 2026.