Rectal CancerPhase 3NCT07113275
A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer
A Phase 3 study testing Short-course radiotherapy, Long-course radiotherapy and Capecitabine in people with Rectal Cancer and Total Neoadjuvant Therapy, run by Tao Zhang at 1 site in China.
Trial summary
This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Total Neoadjuvant Therapy, Radiotherapy
- What is being tested?
- Short-course radiotherapy, Long-course radiotherapy and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 31 Dec 2028
- Phase
- Phase 3
- 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
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed Locally Advanced rectal adenocarcinoma;
- Immunohistochemistry and/or genetic testing confirmed pMMR/MSS;
- inferior margin ≤ 10 cm from the anal verge;
- ECOG performance status score is 0-1;
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- Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;
- There was no operative contraindication;
- Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Urinary protein < 2+ or 24-hour urinary protein excretion < 1 g at baseline.
Who cannot join
- Patients with MSI-H/dMMR LARC；
- Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;
- Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tao Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tao Zhang, MD, 027-85871982, 1277577866@qq.com
About this study
Official title: A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer
This study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.
Read the detailed description
This study is a national multicenter, prospective randomized, placebo- controlled phase III clinical trial, with the following objectives: 1. For patients with LARC, to determine whether the efficacy of TNT combined with immunotherapy is superior to that of the treatment mode of LCRT followed by TNT; 2. To compare the differences in efficacy and toxicity between long-course radiotherapy and short-course radiotherapy under the mode of TNT combined with immunotherapy.
For precision management of patients with cCR post-neoadjuvant therapy, dynamic MRD monitoring was implemented, including baseline and follow-up testing for patients having tumors ≤5 cm from the anal verge.
- Conditions
- Rectal Cancer, Total Neoadjuvant Therapy, Radiotherapy, Immunotherapy
- Being tested
- Short-course radiotherapy, Long-course radiotherapy, Capecitabine, Oxaliplatin, HLX10
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
Also called SCRT
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
Long-course radiotherapyRadiation
Long-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine.
CapecitabineDrug
1000mg/m2, bid, po, d1-14,q3w
OxaliplatinDrug
130mg/m2, ivgtt, d1,q3w
HLX10Drug
300mg, ivgtt, q3w
TME surgeryProcedure or surgery
The surgery was performed 1 week after the end of neoadjuvant therapy.
HLX10 placeboDrug
300mg, ivgtt, q3w
| Study group | Role | What they receive |
|---|---|---|
| Group A: SCRT + iTNT | Experimental | Group A: SCRT + iTNT
Radiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days).
Immunotherapy (HLX10): 300 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion.
Chemotherapy (CAPEOX regimen):
Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1.
Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14.
Cycle duration: 3 weeks per cycle; total of 6 cycles during the neoadjuvant phase.
Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Radiation: Short-course radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Drug: HLX10; Procedure: TME surgery |
| Group B: LCRT + iTNT | Experimental | Group B: LCRT + iTNT
Radiotherapy with Concurrent Chemotherapy (LCRT):
Total dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week).
Concurrent Capecitabine: 825 mg/m² orally twice daily, 5 days per week (administered on radiotherapy days).
Immunotherapy (HLX10): 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion.
Chemotherapy (CAPEOX regimen):
Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1.
Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14.
Cycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase.
Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Radiation: Long-course radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Drug: HLX10; Procedure: TME surgery |
| Group C: LCRT + TNT | Active comparator | Group C: LCRT + TNT
Radiotherapy with Concurrent Chemotherapy (LCRT):
Total dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week).
Concurrent Capecitabine: 825 mg/m² orally twice daily, 5 days per week (administered on radiotherapy days).
TNT Chemotherapy (CAPEOX regimen) with immunotherapy placebo:
HLX10 placebo: 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion.
Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1.
Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14.
Cycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase.
Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. Receives: Radiation: Long-course radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Procedure: TME surgery; Drug: HLX10 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year event-Free Survival
The time from the start of treatment to the occurrence of any of the following events, which ever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause
Measured: an expected average of 3 years
Secondary outcomes (3)
complete response (CR) rate
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
Measured: an expected average of 12 months
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Measured: an expected average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 May 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Zhenyu Lin, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113275
- Sponsor's protocol ID
- XHZDZLK
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter, Randomized, Placebo-Controlled Phase III Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07113275
- Acronym / sponsor ID
- XHZDZLK
- Conditions
- Rectal Cancer, Total Neoadjuvant Therapy, Radiotherapy, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Aug 2025 (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 study is a national multicenter, prospective randomized, placebo- controlled Phase III clinical trial designed to investigate the potential therapeutic benefit of immunotherapy combined with total neoadjuvant therapy (TNT) and to compare the efficacy of different radiotherapy modalities followed by immunotherapy.
Detailed description
This study is a national multicenter, prospective randomized, placebo- controlled phase III clinical trial, with the following objectives: 1. For patients with LARC, to determine whether the efficacy of TNT combined with immunotherapy is superior to that of the treatment mode of LCRT followed by TNT; 2. To compare the differences in efficacy and toxicity between long-course radiotherapy and short-course radiotherapy under the mode of TNT combined with immunotherapy.
For precision management of patients with cCR post-neoadjuvant therapy, dynamic MRD monitoring was implemented, including baseline and follow-up testing for patients having tumors ≤5 cm from the anal verge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: SCRT + iTNT | Experimental | Radiation: Short-course radiotherapy, Drug: Capecitabine, Drug: Oxaliplatin, Drug: HLX10, Procedure: TME surgeryGroup A: SCRT + iTNT Radiotherapy (SCRT): Total dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days). Immunotherapy (HLX10): 300 mg via intravenous infusion every 3 weeks (q3w) for 6 cycles, initiated 1 week after radiotherapy completion. Chemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; total of 6 cycles during the neoadjuvant phase. Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
| Group B: LCRT + iTNT | Experimental | Radiation: Long-course radiotherapy, Drug: Capecitabine, Drug: Oxaliplatin, Drug: HLX10, Procedure: TME surgeryGroup B: LCRT + iTNT Radiotherapy with Concurrent Chemotherapy (LCRT): Total dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week). Concurrent Capecitabine: 825 mg/m² orally twice daily, 5 days per week (administered on radiotherapy days). Immunotherapy (HLX10): 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion. Chemotherapy (CAPEOX regimen): Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase. Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
| Group C: LCRT + TNT | Active comparator | Radiation: Long-course radiotherapy, Drug: Capecitabine, Drug: Oxaliplatin, Procedure: TME surgery, Drug: HLX10 placeboGroup C: LCRT + TNT Radiotherapy with Concurrent Chemotherapy (LCRT): Total dose 50.4 Gy delivered in 28 fractions (1.8 Gy per fraction, once daily, 5 days per week). Concurrent Capecitabine: 825 mg/m² orally twice daily, 5 days per week (administered on radiotherapy days). TNT Chemotherapy (CAPEOX regimen) with immunotherapy placebo: HLX10 placebo: 300 mg IV infusion q3w for 6 cycles, initiated 2 weeks after radiotherapy completion. Oxaliplatin: 130 mg/m² IV infusion over 120 minutes on Day 1. Capecitabine: 1000 mg/m² orally twice daily (morning and evening, 30 minutes after meals) on Days 1-14. Cycle duration: 3 weeks per cycle; initiated 2 weeks post-radiotherapy; total of 6 cycles during the neoadjuvant phase. Then followed by a total mesorectal excision(TME) or Watch \& Wait strategy for clinical complete remission voluntary patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed Locally Advanced rectal adenocarcinoma;
- Immunohistochemistry and/or genetic testing confirmed pMMR/MSS;
- inferior margin ≤ 10 cm from the anal verge;
Key exclusion criteria (3 listed)
- Patients with MSI-H/dMMR LARC；
- Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms;
- Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).
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 radiotherapyAlso: SCRTEligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy. | Radiation | Group A: SCRT + iTNT |
| Long-course radiotherapyLong-course radiotherapy (LCRT, 50.4 Gy administered in 28 fractions) will be delivered concurrently with oral capecitabine. | Radiation | Group B: LCRT + iTNT, Group C: LCRT + TNT |
| Capecitabine1000mg/m2, bid, po, d1-14,q3w | Drug | Group A: SCRT + iTNT, Group B: LCRT + iTNT, Group C: LCRT + TNT |
| Oxaliplatin130mg/m2, ivgtt, d1,q3w | Drug | Group A: SCRT + iTNT, Group B: LCRT + iTNT, Group C: LCRT + TNT |
| HLX10300mg, ivgtt, q3w | Drug | Group A: SCRT + iTNT, Group B: LCRT + iTNT |
| TME surgeryThe surgery was performed 1 week after the end of neoadjuvant therapy. | Procedure or surgery | Group A: SCRT + iTNT, Group B: LCRT + iTNT, Group C: LCRT + TNT |
| HLX10 placebo300mg, ivgtt, q3w | Drug | Group C: LCRT + TNT |
Primary outcome
3-year event-Free Survival
Time frame: an expected average of 3 years
The time from the start of treatment to the occurrence of any of the following events, which ever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause
3 secondary outcomes
complete response (CR) rate
Time frame: an expected average of 12 months
Overall Survival
Time frame: an expected average of 5 years
Adverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time frame: an expected average of 1.5 years
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 13 May 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.
Tao Zhang, MD contact
Zhenyu Lin, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short-course radiotherapy, Long-course radiotherapy and Capecitabine in people with Rectal Cancer and Total Neoadjuvant Therapy, run by Tao Zhang 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 10 inclusion and 3 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 13 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zhenyu Lin, MD (027-85871982, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year event-Free Survival (time frame: an expected average of 3 years). 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 13 May 2026.