Rectal CancerPhase 2TRIUNITE-03NCT06718543
Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
A Phase 2 study testing AK112 with SCRT and CapeOX and AK112 with SCRT in people with Rectal Cancer, run by fan li at 1 site in China.
Trial summary
This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- AK112 with SCRT and CapeOX and AK112 with SCRT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 31 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age 18-80 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
- Able to swallow tablets.
- ECOG Performance Status of 0-1.
- No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy.
- 9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge
Who cannot join
- Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
- Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.
- 4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).
- 7.Severe infection within 4 weeks or active pulmonary infections. 8.Active hepatitis B or C infection. 9.Diagnosis of other malignancies within 5 years (except low-risk cancers). 10.Pregnant or breastfeeding women.
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
Daping Hospital
Chongqing, Chongqing Municipality, 400000
Fan Li, PhD, +8618696539200, levinecq@163.com
Haode Shen, MD, +8617783437391, imshd@qq.com
About this study
Official title: A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer
This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.
Read the detailed description
The study is designed as a two-arm, randomized, open-label, prospective trial. Patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups:
Arm A: SCRT followed by chemotherapy (CapeOX) combined with AK112. Arm B: SCRT followed by AK112 alone. Primary and secondary outcome measures include complete response rate (CR), safety, pathological and radiological response rates, and biomarkers associated with treatment response. The trial will enroll 100 participants across multiple centers over three years.
- Conditions
- Rectal Cancer
- Being tested
- AK112 with SCRT and CapeOX, AK112 with SCRT
- Keywords
- rectal cancer, neoadjuvant, Ivonescimab, Immunotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112 with SCRT and CapeOXDrug
Also called short-course radiotherapy, CapeOX
In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally).
AK112 with SCRTDrug
In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion).
| Study group | Role | What they receive |
|---|---|---|
| SCRT followed by CapeOX regimen combined with AK112 | Experimental | Patients will receive short-course radiotherapy (SCRT) followed by chemotherapy (CapeOX regimen) combined with AK112:
In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally). Receives: Drug: AK112 with SCRT and CapeOX |
| SCRT followed by AK112 | Experimental | Patients will receive short-course radiotherapy (SCRT) followed by AK112:
In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion). Receives: Drug: AK112 with SCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Proportion of patients achieving either a pathological complete response (pCR) or a clinical complete response (cCR).
Measured: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).
Secondary outcomes (9)
Adverse Events (AEs)
Incidence, type, and severity of adverse events graded according to CTCAE v5.0, including their correlation with the study drug.
Measured: From baseline to 90 days after the last treatment dose.
Major Pathological Response (MPR)
Proportion of patients with ≤10% residual viable tumor cells in resected specimens.
Measured: At the time of surgery (approximately 12 weeks after treatment initiation).
Objective Response Rate (ORR)
Proportion of patients with complete response (CR) or partial response (PR) based on radiological assessments using RECIST 1.1 criteria.
Measured: Approximately 12 weeks after treatment initiation.
Progression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause.
Measured: Up to 36 months post-randomization.
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: Up to 36 months post-randomization.
Organ Preservation Rate (OPR)
Proportion of patients avoiding major surgery while retaining organ functionality.
Measured: Approximately 12 months post-treatment initiation.
Tumor Response Based on RECIST 1.1
Evaluation of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) using RECIST 1.1 criteria.
Measured: Approximately 12 weeks after treatment initiation.
Clinical Complete Response Rate (cCR)
Proportion of patients achieving clinical complete response based on clinical examination and imaging assessments.
Measured: Approximately 12 weeks after treatment initiation.
Pathological Complete Response (pCR)
Absence of tumor cells in the primary tumor and regional lymph nodes in surgical specimens.
Measured: Approximately 12 weeks after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start10 Feb 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- fan li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718543
- Sponsor's protocol ID
- TRIUNITE-03
- Acronym
- TRIUNITE-03
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06718543
- Acronym / sponsor ID
- TRIUNITE-03 / TRIUNITE-03
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, neoadjuvant, Ivonescimab, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- fan liUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Dec 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.
This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.
Detailed description
The study is designed as a two-arm, randomized, open-label, prospective trial. Patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups:
Arm A: SCRT followed by chemotherapy (CapeOX) combined with AK112. Arm B: SCRT followed by AK112 alone. Primary and secondary outcome measures include complete response rate (CR), safety, pathological and radiological response rates, and biomarkers associated with treatment response. The trial will enroll 100 participants across multiple centers over three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRT followed by CapeOX regimen combined with AK112 | Experimental | Drug: AK112 with SCRT and CapeOXPatients will receive short-course radiotherapy (SCRT) followed by chemotherapy (CapeOX regimen) combined with AK112: In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally). |
| SCRT followed by AK112 | Experimental | Drug: AK112 with SCRTPatients will receive short-course radiotherapy (SCRT) followed by AK112: In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent.
- Age 18-80 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
- Able to swallow tablets.
Key exclusion criteria (4 listed)
- Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
- Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.
- 4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).
- 7.Severe infection within 4 weeks or active pulmonary infections. 8.Active hepatitis B or C infection. 9.Diagnosis of other malignancies within 5 years (except low-risk cancers). 10.Pregnant or breastfeeding women.
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 |
|---|---|---|
| AK112 with SCRT and CapeOXAlso: short-course radiotherapy, CapeOXIn the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally). | Drug | SCRT followed by CapeOX regimen combined with AK112 |
| AK112 with SCRTIn the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion). | Drug | SCRT followed by AK112 |
Primary outcome
Complete Response Rate
Time frame: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).
Proportion of patients achieving either a pathological complete response (pCR) or a clinical complete response (cCR).
9 secondary outcomes
Adverse Events (AEs)
Time frame: From baseline to 90 days after the last treatment dose.
Major Pathological Response (MPR)
Time frame: At the time of surgery (approximately 12 weeks after treatment initiation).
Objective Response Rate (ORR)
Time frame: Approximately 12 weeks after treatment initiation.
Progression-Free Survival (PFS)
Time frame: Up to 36 months post-randomization.
Overall Survival (OS)
Time frame: Up to 36 months post-randomization.
Organ Preservation Rate (OPR)
Time frame: Approximately 12 months post-treatment initiation.
Tumor Response Based on RECIST 1.1
Time frame: Approximately 12 weeks after treatment initiation.
Clinical Complete Response Rate (cCR)
Time frame: Approximately 12 weeks after treatment initiation.
Pathological Complete Response (pCR)
Time frame: Approximately 12 weeks after treatment initiation.
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 AK112 with SCRT and CapeOX and AK112 with SCRT in people with Rectal Cancer, run by fan li 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 8 inclusion and 4 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 10 Apr 2025. 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 Fan LI, PhD (+8618696539200, levinecq@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 (time frame: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).). 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 10 Apr 2025.