Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）

ConditionLocally Advanced Rectal Cancer

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorJIN JING

About this trial

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 18-75 years old, gender is not limited;

2. Stage II/III under MRI or endoscopic ultrasound ;

3. Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;

4. Rectal adenocarcinoma confirmed or revisited by pathology;

Disqualifiers

1. Previous anti-PD-1/L1 and anti-CTLA-4 immune drugs or other immunoassay drugs;

2. With severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;

3. Symptomatic interstitial lung disease or active infection/non-infectious pneumonia;

4. Patients have risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for intestinal perforation;

Trial design

Design model

Sequential

Treatments tested in this trial

AK104 injection
Drug
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
TME surgery
Procedure/Surgery
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
Capecitabine
Drug
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
Oxaliplatin
Drug
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).

Treatment groups

50 Participants

are divided into 3 treatment groups

Group A: AK104 injection++chemotherapyExperimental treatment 4 interventions

Group B: TME surgeryExperimental treatment 4 interventions

Group C: chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Pathologic complete response rate (pCR)

To assess the result from pathology report

Time frame

From date of randomization until the date of end of treatment,about 18 weeks.

Secondary outcomes

Major pathologic response rate (MPR)

To assess the result from pathology report

Time frame

From date of randomization until the date of end of treatment,about 18 weeks.

3-years DFS rate

To compute the length between end of treatment and relapse

Time frame

From date of randomization until the date of first documented disease relapse or date of death from any cause, whichever came first about 3years..

3-years OS rate

To compute the length between end of treatment and death

Time frame

From date of randomization until date of death from any cause,about 3 years.

Incidence and severity of adverse events (AEs) and clinically meaningful abnormal laboratory test results

To assess the result from inspection paper during the trail

Time frame

From date of randomization until the date of end of treatment,about 18 weeks.

Other outcomes

Relationship between the expression of immune markers in tumor tissues and blood,the distribution of immune cells, and the efficacy and prognosis of patients

To use PCR to check the immune markers in blood and use immunofluorescent cytochemical techniques to check the immune markers in tumor tissues.The concentration of antigens and antibodies in the blood is measured to determine the efficacy and concentration of the drug after the subject's medication

Time frame

From date of randomization until the date of end of treatment,about 18 weeks.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JIN JING

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov

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