Locally Advanced Rectal CancerPhase 2NCT06802666
Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
A Phase 2 study testing short-course radiotherapy, Ivonescimab and capecitabine in people with Locally Advanced Rectal Cancer and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with 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, Neoadjuvant Therapy
- What is being tested?
- short-course radiotherapy, Ivonescimab and capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2024to 30 Dec 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
- The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance；
- Age ≥18 years and ≤75 years, without gender restriction.
- Histopathologically confirmed locally advanced rectal adenocarcinoma.
- Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy.
- Hematological parameters at baseline* (within 7 days prior to the first dose of study drug) must meet the following criteria: • Hemoglobin ≥90 g/L • Absolute neutrophil count (ANC) ≥1.5×10^9/L • Platelet count ≥100×10^9/L • Eosinophils ≤1.5×upper limit of normal (ULN). *Participants may not have received blood products (including red cell suspensions, plateletpheresis, cryoprecipitate), erythropoietin, or colony-stimulating factor supportive treatment within 7 days prior to blood sampling.
- Serum biochemical tests at baseline (within 7 days prior to the first dose) must meet the following criteria: • Total bilirubin ≤1.5×ULN (if total bilirubin >1.5×ULN, direct bilirubin ≤ULN is acceptable for inclusion). • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN. • Serum creatinine ≤1.5×ULN or creatinine clearance (CCr) ≥45 mL/min, calculated using the Cockcroft-Gault formula (Appendix 4) using actual body weight. • Albumin ≥30 g/L.
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- Coagulation tests at baseline (within 7 days prior to the first dose) must meet the following criteria: • International normalized ratio (INR) ≤1.5×ULN (≤3×ULN if on stable anticoagulant therapy). • Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN (≤3×ULN if on stable anticoagulant therapy).
- Urinalysis at baseline (within 7 days prior to the first dose) must meet the following criteria: urine protein (UPRO) <2+ or 24-hour urinary protein <1 g.
- At least one measurable lesion according to RECIST v1.1 (solid tumors) criteria.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Expected survival ≥3 months.
- Women of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the end of treatment.
Who cannot join
- Exclusion of patients not diagnosed with locally advanced rectal adenocarcinoma.
- Participants who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or any other treatments targeting tumor immunological mechanisms, such as immune cell therapy.
- Pregnant or breastfeeding women, or women planning to become pregnant during the period from before the administration of the study drug, during treatment, or up to 6 months after the last dose.
- Known history of active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, or new onset of brain or leptomeningeal metastases.
- Significant cardiovascular diseases of clinical importance.
- History of allergic constitution, asthma, or atopic dermatitis.
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- Participants with large pleural effusion or ascites.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Participants known or suspected to be allergic to the investigational product or any of its excipients.
- Participants with a history of significant toxicities associated with prior administration of immune checkpoint inhibitors or treatment with bevacizumab/pirfenidone-like agents that required permanent discontinuation of such treatment.
- Participants with unresolved toxicity > Grade 1 related to any prior anticancer therapy (excluding persistent alopecia Grade 2, peripheral neuropathy, anemia, or hypomagnesemia).
- Active uncontrolled bleeding or known bleeding diathesis, serious non-healing wounds, ulcers, or bone fractures, such as esophageal or gastric varices requiring immediate intervention (e.g., band ligation or sclerotherapy), or signs of portal hypertension where the Investigator believes the risk of bleeding is high.
- Participants with a history of bowel obstruction (excluding those who have undergone curative surgery or have had complete resolution) or gastrointestinal perforation risk within 28 days prior to the first dose of this study (including but not limited to acute diverticulitis, abdominal abscess, peritoneal carcinomatosis, history of gastrointestinal perforation and/or fistula within 6 months prior to study entry).
- Current or recent (within 6 months) major gastrointestinal diseases or conditions in participants, including:
- Clinically significant history of gastrointestinal bleeding.
- Active peptic ulcer disease.
- ≥Grade 2 diarrhea occurring within 2 weeks prior to the first dose of the study drug.
- Participants who have received chemotherapy, small molecule inhibitors, immunotherapy (such as interleukins, interferons, or thymosin) for cancer treatment within 28 days before this study, or traditional Chinese medicine with anti-cancer indications within 14 days prior to dosing.
- Known positive HIV test result, active hepatitis B, hepatitis C (HCV), tuberculosis, or a history of infection with these diseases.
- Serious/active/uncontrolled infection or infection requiring systemic intravenous antibiotics, or fever of unknown origin (>38°C) within 2 weeks prior to the first dose of the study drug.
- Diagnosis of another malignancy within 5 years prior to the first dose, except for cases such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been surgically resected, as well as localized prostate cancer or papillary thyroid cancer post-radical surgery.
- Participants who have received radical radiotherapy within 3 months prior to this study; palliative radiotherapy is allowed if administered at least 2 weeks prior to dosing and the radiation dose is consistent with local standards for palliative care.
- Presence of any medical condition, therapy, laboratory abnormality, or history of drug abuse, or current evidence thereof, which in the opinion of the investigator might jeopardize the safety of the participant, interfere with obtaining informed consent, affect the participant's compliance, or impact the assessment of the safety of the study drug.
- Patients whom the investigator deems unsuitable for participation in the clinical trial.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei
Zhenyu Lin Lin, MD, 027-85871982, whxhlzy@hust.edu.cn
Zhenyu Lin, MD
About this study
Official title: Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study
This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer
Read the detailed description
Study includes a screening period (from the time the participant signs the informed consent form until the first treatment, not exceeding 21 days), treatment period (including full neoadjuvant therapy, surgery, and postoperative adjuvant treatment), and follow-up period (including safety follow-up and survival follow-up ).
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W.The surgery was performed 1 week after the end of neoadjuvant therapy.After surgery, the investigator conducts a pathological assessment of the surgical specimen for response evaluation. Then, there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.
- Being tested
- short-course radiotherapy, Ivonescimab, capecitabine, oxaliplatin, TME surgery
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 combined with AK112 regimen for 6 cycles.
IvonescimabDrug
Also called AK112
AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W)
capecitabineDrug
1000mg/m2, bid, po, d1-14,q3w
oxaliplatinDrug
130mg/m2, ivgtt, d1,q3w
TME surgeryProcedure or surgery
The surgery was performed 1 week after the end of neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| SCRT+AK112+chemotherapy | Experimental | short-course radiotherapy followed by sequential chemotherapy and AK112 Receives: Radiation: short-course radiotherapy; Drug: Ivonescimab; Drug: capecitabine; Drug: oxaliplatin; Procedure: TME surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate (pCR)
Pathological complete response will be made based on assessment of the surgical specimen at the primary treatment site，the absence of any viable tumor cells in the resected primary tumor specimen and all regional lymph node samples.
Measured: though 19 weeks neoadjuvant treatment，after surgery completed
Secondary outcomes (8)
3-years Event-Free Survival rate
from the start of randomized treatment assignment until the occurrence of a predefined event
Measured: 3 years
OS
To compute the length between end of treatment and death
Measured: From date of randomization until date of death from any cause，up to 3 years
R0 resection rate
The rate of negative margin microscopically
Measured: From date of surgry，up to 1month
AE
To assess the result from inspection paper during the trail，adverse events (AEs) were graded according to the NCl CTCAE version 5.0
Measured: up to 3 years
30-day postoperative mortality rates
30-day mortality rate after rectal cancer surgery
Measured: 30 days post surgery
Surgical complications
Possible complications that may occur after rectal cancer surgery
Measured: After surgery，up to 3years
90-day postoperative mortality rates
90-day mortality rate after rectal cancer surgery
Measured: 90 days post surgery
length of hospital stay
Length of Postoperative Hospital Stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start16 Oct 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- single arm
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Lin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Tao Zhang, MD, Study director, Union Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802666
- Sponsor's protocol ID
- AK112-IIT-C-S-0010
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 31 Jan 2025
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06802666
- Acronym / sponsor ID
- AK112-IIT-C-S-0010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Jan 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 aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer
Detailed description
Study includes a screening period (from the time the participant signs the informed consent form until the first treatment, not exceeding 21 days), treatment period (including full neoadjuvant therapy, surgery, and postoperative adjuvant treatment), and follow-up period (including safety follow-up and survival follow-up ).
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W.The surgery was performed 1 week after the end of neoadjuvant therapy.After surgery, the investigator conducts a pathological assessment of the surgical specimen for response evaluation. Then, there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm
| Arm | Type | Receives |
|---|---|---|
| SCRT+AK112+chemotherapy | Experimental | Radiation: short-course radiotherapy, Drug: Ivonescimab, Drug: capecitabine, Drug: oxaliplatin, Procedure: TME surgeryshort-course radiotherapy followed by sequential chemotherapy and AK112 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance；
- Age ≥18 years and ≤75 years, without gender restriction.
- Histopathologically confirmed locally advanced rectal adenocarcinoma.
- Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy.
- Hematological parameters at baseline* (within 7 days prior to the first dose of study drug) must meet the following criteria: • Hemoglobin ≥90 g/L • Absolute neutrophil count (ANC) ≥1.5×10^9/L • Platelet count ≥100×10^9/L • Eosinophils ≤1.5×upper limit of normal (ULN). *Participants may not have received blood products (including red cell suspensions, plateletpheresis, cryoprecipitate), erythropoietin, or colony-stimulating factor supportive treatment within 7 days prior to blood sampling.
Key exclusion criteria (25 listed)
- Exclusion of patients not diagnosed with locally advanced rectal adenocarcinoma.
- Participants who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or any other treatments targeting tumor immunological mechanisms, such as immune cell therapy.
- Pregnant or breastfeeding women, or women planning to become pregnant during the period from before the administration of the study drug, during treatment, or up to 6 months after the last dose.
- Known history of active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, or new onset of brain or leptomeningeal metastases.
- Significant cardiovascular diseases of clinical importance.
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 combined with AK112 regimen for 6 cycles. | Radiation | SCRT+AK112+chemotherapy |
| IvonescimabAlso: AK112AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W) | Drug | SCRT+AK112+chemotherapy |
| capecitabine1000mg/m2, bid, po, d1-14,q3w | Drug | SCRT+AK112+chemotherapy |
| oxaliplatin130mg/m2, ivgtt, d1,q3w | Drug | SCRT+AK112+chemotherapy |
| TME surgeryThe surgery was performed 1 week after the end of neoadjuvant therapy. | Procedure or surgery | SCRT+AK112+chemotherapy |
Primary outcome
Pathologic complete response rate (pCR)
Time frame: though 19 weeks neoadjuvant treatment，after surgery completed
Pathological complete response will be made based on assessment of the surgical specimen at the primary treatment site，the absence of any viable tumor cells in the resected primary tumor specimen and all regional lymph node samples.
8 secondary outcomes
3-years Event-Free Survival rate
Time frame: 3 years
OS
Time frame: From date of randomization until date of death from any cause，up to 3 years
R0 resection rate
Time frame: From date of surgry，up to 1month
AE
Time frame: up to 3 years
30-day postoperative mortality rates
Time frame: 30 days post surgery
Surgical complications
Time frame: After surgery，up to 3years
90-day postoperative mortality rates
Time frame: 90 days post surgery
length of hospital stay
Time frame: through study completion, an average of 1 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 Jan 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.
Tao Zhang, MD study director
Union Hospital affiliated to Tongji Medical College of Huazhong University ofScience 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 2 study testing short-course radiotherapy, Ivonescimab and capecitabine in people with Locally Advanced Rectal Cancer and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 12 inclusion and 25 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 Jan 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 tao Zhang, MD (02785871982, 1277577866@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (pCR) (time frame: though 19 weeks neoadjuvant treatment，after surgery completed). 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 Jan 2025.