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New cocktail attack on stubborn colon cancer

NCT ID NCT07622550

Disease control Sponsor: Jiangsu Cancer Institute & Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a combination of two targeted drugs (fruquintinib and serplulimab) plus chemotherapy as a first treatment for 80 people with advanced colorectal cancer that has RAS or BRAF mutations. The goal is to see if this mix can delay cancer growth and improve survival. Participants will receive the drugs in cycles, followed by maintenance therapy if their disease is controlled.

What this could mean

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

Active substance
fruquintinib, serplulimab, and chemotherapy (oxaliplatin and capecitabine)
What this could lead to
If successful, this could offer a new first-line treatment option for people with a hard-to-treat form of advanced colorectal cancer.
What could go wrong
This is a small, early-phase (phase 2) trial with no control group, so results may not be definitive. The drug combination may cause significant side effects.

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 80 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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: * 18 to 75 years (inclusive), male or female. * Diagnosis of advanced unresectable or metastatic colorectal cancer. * Confirmed RAS/BRAF mutation by testing. * No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.) * ECOG 0 - 1. * Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment): 1. Hematology: absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L. 2. International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN. 3. Liver function: total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases). 4. Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL/min. * Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose Exclusion Criteria: * \- History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs. * Untreated central nervous system (CNS) metastases. * Major surgery or severe trauma within 4 weeks prior to first study drug administration. * Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment. * Presence of any active autoimmune disease or history of autoimmune disease. * History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. * Known inherited or acquired bleeding/thrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy. * Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Metastatic colorectal cancer (CRC)

How to take part

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

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Changshu No.2 People's Hospital

    Suzhou, Jiangsu, 215000, China

  • Changzhou Tumor Hospital (Changzhou Fourth People's Hospital)

    Changzhou, Jiangsu, 213000, China

  • First Affiliated Hospital of Nanjing Medical Unviersity

    Nanjing, Jiangsu, 210000, China

  • Huaian First People's Hospital

    Huai'an, Jiangsu, 223000, China

  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu, 210000, China

  • Jiangyin People's Hospital

    Wuxi, Jiangsu, 214400, China

  • Liyang People's Hospital

    Changzhou, Jiangsu, 213000, China

  • Nantong University Cancer Hospital

    Nantong, Jiangsu, 226000, China

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215000, China

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213000, China

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222000, China

  • The First People's Hospital of Nantong

    Nantong, Jiangsu, 226000, China

  • Wuxi Huishan District People's Hospital

    Wuxi, Jiangsu, 214000, China

  • Xuzhou First People's Hospital

    Xuzhou, Jiangsu, 221000, China

  • Yangzhou University Affiliated Jiangdu People's Hospital

    Yangzhou, Jiangsu, 225000, China

  • Yizheng People's Hospital

    Yangzhou, Jiangsu, 225000, China

More trials for these conditions

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