Locally Advanced Rectal CancerPhase 2NCT05845268
Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced of Middle and Low Rectal Cancer
A Phase 2 study testing Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor) and Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor) in people with Locally Advanced Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study is a prospective, randomized, open, controlled, multi-center phase II clinical trial, which included patients with locally advanced low rectal cancer as the research object, and evaluated the application of long-term concurrent chemoradiotherapy combined with tislelizumab versus long-term synchronous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor) and Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
- Patients with rectal cancers must satisfied all the following conditions:Stage II/III LARC (cT3-4aN0M0 and cT1-4aN1-2M0);Tumor distal location ≤ 10 cm from anal verge (MRI diagnosed);
- Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
- Physical and viscera function of patients can withstand major abdominal surgery;
- Patients are willing and able to follow the study protocol during the study;
- Patients give consent to the use of blood and pathological specimens for study;
- Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.
Who cannot join
- Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
- Patients underwent major surgery within 4 weeks prior to study treatment;
- Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
- Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- Patients who are allergic to any of the ingredients under study;
- Patients with severe concomitant diseases with estimated survival ≤ 5 years;
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- Patients with present or previous moderate or severe liver and kidney damage presently or previously;
- Patients have received other study medications or any immunotherapy currently or in the past;
- Patients preparing for or previously received organ or bone marrow transplant;
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
- Patients with congenital or acquired immune deficiency (such as HIV infection);
- If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;
- Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yao Hongwei, M.D, 86 13611015609, yaohongwei@ccmu.edu.cn
About this study
Official title: Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced Phase II Randomized Controlled Clinical Study of Middle and Low Rectal Cancer
This study is a prospective, randomized, open, controlled, multi-center phase II clinical trial, which included patients with locally advanced low rectal cancer as the research object, and evaluated the application of long-term concurrent chemoradiotherapy combined with tislelizumab versus long-term synchronous Efficacy and safety of chemotherapy and radiotherapy as neoadjuvant therapy for patients with locally advanced rectal cancer. The main endpoints of the study were clinical complete response (cCR) (including imaging and endoscopic complete response) and pathological complete response (pathological complete response, pCR). Secondary study endpoints are primary pathological response rate (MPR), objective response rate (ORR), disease-free survival (DFS), overall survival (OS), organ preservation rate (OPR), rectal cancer neoadjuvant therapy score (NAR ), quality of life score (QoL), safety and tolerability. They will be randomly divided into an experimental group (tislelizumab combined with long-term concurrent chemoradiotherapy) and a control group (long-term concurrent chemoradiotherapy) at a ratio of 2:1. Random stratification factors: 1. TNM stage (II/III); 2. Distance from the tumor to the anal verge (≥5cm, <5cm).
Read the detailed description
This study plans to recruit 102 patients, aged 18-75 years old, male or female; rectal adenocarcinoma confirmed by histopathology; clinical stage II-III assessed by MRI (according to AJCC 8th edition); Margin ≤ 10 cm; surgical resection is possible.All patients should have no history of immune diseases, nor history of immunotherapy or radiotherapy. Eligible participants will be randomly assigned to Experiment Arm (50.4Gy radiation, capecitabine, and anti-PD1 starting at Day 8 of radiation) and Control Arm (50.4Gy radiation, capecitabine) in a 2：1ratio.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor), Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor)
- Keywords
- neoadjuvant, Tislelizumab, PD-1, chemoradiation, LARC, randomized, controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor)Combination product
Tislelizumab was added to long-course chemoradiotherapy (CRT) in LARC patients, CRT + concurrent tislelizumab was used in the Experimental arm, and CRT was used in the Active Comparator arm.
Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor)Combination product
Tislelizumab was added to long-course chemoradiotherapy (CRT) in LARC patients, CRT + concurrent tislelizumab was used in the Experimental arm, and CRT was used in the Active Comparator arm.
| Study group | Role | What they receive |
|---|---|---|
| CRT+concurrent PD-1 inhibition | Experimental | Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 10~13 weeks after completion of radiation. Receives: Combination Product: Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor) |
| CRT without PD-1 inhibition | Active comparator | Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 10~13 weeks after completion of radiation. Receives: Combination Product: Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete response rate
Measured: within 10 days after surgery
cCR rate
clinical complete response rate
Measured: 12-13 weeks after radiotherapy ends
Secondary outcomes (4)
NAR score
Neoadjuvant rectal（NAR）score：It is based on the scoring criteria of preoperative treatment downstaging. The range is 0-201.46, with higher scores indicating worse prognosis.
Measured: within 10 days after surgery
OPR
organ preservation rate
Measured: immediately after surgery
ORR
objective response rate
Measured: within 10 days after surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with PD-1 inhibition
Measured: up to 30th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Oct 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2025 (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 Beijing Friendship 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Zhongtao, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845268
- Sponsor's protocol ID
- BFH-TNT-LARC
- Status last verified
- Oct 2022
- First submitted
- 30 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Export of individual patient data is a sensitive issue according to current Chinese laws
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Therapy Combined With Tislelizumab for Local Advanced Phase II Randomized Controlled Clinical Study of Middle and Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT05845268
- Acronym / sponsor ID
- BFH-TNT-LARC
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- neoadjuvant, Tislelizumab, PD-1, chemoradiation, LARC, randomized, controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 May 2023 (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 prospective, randomized, open, controlled, multi-center phase II clinical trial, which included patients with locally advanced low rectal cancer as the research object, and evaluated the application of long-term concurrent chemoradiotherapy combined with tislelizumab versus long-term synchronous Efficacy and safety of chemotherapy and radiotherapy as neoadjuvant therapy for patients with locally advanced rectal cancer. The main endpoints of the study were clinical complete response (cCR) (including imaging and endoscopic complete response) and pathological complete response (pathological complete response, pCR). Secondary study endpoints are primary pathological response rate (MPR), objective response rate (ORR), disease-free survival (DFS), overall survival (OS), organ preservation rate (OPR), rectal cancer neoadjuvant therapy score (NAR ), quality of life score (QoL), safety and tolerability. They will be randomly divided into an experimental group (tislelizumab combined with long-term concurrent chemoradiotherapy) and a control group (long-term concurrent chemoradiotherapy) at a ratio of 2:1. Random stratification factors: 1. TNM stage (II/III); 2. Distance from the tumor to the anal verge (≥5cm, <5cm).
Detailed description
This study plans to recruit 102 patients, aged 18-75 years old, male or female; rectal adenocarcinoma confirmed by histopathology; clinical stage II-III assessed by MRI (according to AJCC 8th edition); Margin ≤ 10 cm; surgical resection is possible.All patients should have no history of immune diseases, nor history of immunotherapy or radiotherapy. Eligible participants will be randomly assigned to Experiment Arm (50.4Gy radiation, capecitabine, and anti-PD1 starting at Day 8 of radiation) and Control Arm (50.4Gy radiation, capecitabine) in a 2：1ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT+concurrent PD-1 inhibition | Experimental | Combination Product: Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor)Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 10~13 weeks after completion of radiation. |
| CRT without PD-1 inhibition | Active comparator | Combination Product: Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor)Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 10~13 weeks after completion of radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
- Patients with rectal cancers must satisfied all the following conditions:Stage II/III LARC (cT3-4aN0M0 and cT1-4aN1-2M0);Tumor distal location ≤ 10 cm from anal verge (MRI diagnosed);
- Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
- Physical and viscera function of patients can withstand major abdominal surgery;
- Patients are willing and able to follow the study protocol during the study;
Key exclusion criteria (14 listed)
- Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
- Patients underwent major surgery within 4 weeks prior to study treatment;
- Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
- Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- Patients who are allergic to any of the ingredients under study;
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 |
|---|---|---|
| Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor)Tislelizumab was added to long-course chemoradiotherapy (CRT) in LARC patients, CRT + concurrent tislelizumab was used in the Experimental arm, and CRT was used in the Active Comparator arm. | Combination product | CRT+concurrent PD-1 inhibition |
| Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor)Tislelizumab was added to long-course chemoradiotherapy (CRT) in LARC patients, CRT + concurrent tislelizumab was used in the Experimental arm, and CRT was used in the Active Comparator arm. | Combination product | CRT without PD-1 inhibition |
Primary outcome
pCR rate
Time frame: within 10 days after surgery
pathological complete response rate
cCR rate
Time frame: 12-13 weeks after radiotherapy ends
clinical complete response rate
4 secondary outcomes
NAR score
Time frame: within 10 days after surgery
OPR
Time frame: immediately after surgery
ORR
Time frame: within 10 days after surgery
immune-related adverse event rate
Time frame: up to 30th day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No. Export of individual patient data is a sensitive issue according to current Chinese laws
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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.
Zhang Zhongtao principal investigator
Beijing Friendship Hospital
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 Long-course chemoradiation, with Tislelizumab (PD-1 inhibitor) and Long-course chemoradiation, without Tislelizumab (PD-1 inhibitor) in people with Locally Advanced Rectal Cancer, run by Beijing Friendship 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 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Zhongtao, MD (+8613801060364, zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: within 10 days after surgery). The study lists 2 primary outcomes in all. 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 6 May 2023.