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Personalized Pre-Surgery cocktails aim to wipe out colorectal cancer

NCT ID NCT07503639

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests different drug combinations given before surgery for locally advanced colorectal cancer. The 134 participants are grouped by their tumor's genetic markers, and each group receives a tailored treatment. The main goal is to see how often the cancer completely disappears after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-1701, SHR-8068, XELOX (capecitabine and oxaliplatin), PD-L1 antibody, cetuximab β, HRS-7058, HRS-4642, and short-course radiotherapy
What this could lead to
If successful, this trial could identify which drug combinations work best for different genetic subtypes of colorectal cancer, potentially increasing the chance of complete tumor disappearance before surgery.
What could go wrong
This is an early-phase, single-center trial with only 134 participants, so results may not apply broadly. Some drug combinations may cause significant side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-75 years old, female and male; 2. Pathological confirmed adenocarcinoma; 3. Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge; 4. Treatment-naïve and no distance metastases; 5. KPS ≥ 70; 6. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment; 7. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN; 8. With good compliance and signed the consent form. Exclusion Criteria: 1. Pregnancy or breast-feeding women; 2. Known history of other malignancies within 5 years; 3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy); 4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction; 5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment; 6. Uncontrolled infection which needs systemic therapy; 7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents; 8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection; 9. Allergic to any component of the therapy.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.