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Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

ConditionLocally Advanced Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years old, female and male;

Pathological confirmed adenocarcinoma;

Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge;

Treatment-naïve and no distance metastases;

Disqualifiers

Pregnancy or breast-feeding women;

Known history of other malignancies within 5 years;

Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);

Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1701

    Drug

    1800mg d1 q3w

  • SHR-8068

    Drug

    280mg，C1D1

  • Short-course radiotherapy

    Radiation

    25Gy/5Fx

  • XELOX (Capecitabine and Oxaliplatin)

    Drug

    Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w

  • PD-L1 antibody

    Drug

    1200mg d1 q3w

  • cetuximab β

    Drug

    250mg/m2 d1, 500mg/m2 d8 q3w

  • HRS-7058

    Drug

    200mg bid

  • HRS-4642

    Drug

    500mg d1, 1200mg d8 q3w

Treatment groups

134 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: MSI-H/dMMRExperimental treatment 2 interventions
Group B: MSS-KRAS G12C-AdebrelimabExperimental treatment 4 interventions
Group C: MSS-KRAS G12C-cetuximab βExperimental treatment 4 interventions
Group D: MSS-KRAS G12D-AdebrelimabExperimental treatment 4 interventions
Group E: MSS-KRAS G12D-cetuximab βExperimental treatment 4 interventions
Group F: MSS-CMSExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Complete response (CR) rate: rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.

Time frame
1 month after the surgery or 1 year after the decision of W&W.

Secondary outcomes

1

Adverse effects rate: proportion of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0.

Time frame
From date of stratification to 3 months post-neoadjuvant therapy, an average of 8 months.
2

Organ preservation rate: proportion of participants who either achieve cCR and choose W&W or achieve cCR/near-cCR and choose local excision, out of the total participants who complete neoadjuvant therapy.

This endpoint is applicable only to patients with locally advanced rectal cancer.

Time frame
From date of stratification until the resection of rectum or anus, assessed up to 36 months.
3

R0 resection rate: proportion of surgical resections with negative margins (proximal, distal, and circumferential) on microscopic examination, with CRM negativity defined as > 1 mm from tumor bed.

Time frame
1 month after the surgery.
4

Rate of surgical complications: rates of surgical complications such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

Time frame
within 3 months after the surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: