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Can we predict who will benefit from immunotherapy? new study aims to find out.

NCT ID NCT07147361

Knowledge-focused Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study is looking for biological markers (biomarkers) that might predict how well patients with certain types of squamous cell carcinoma respond to a type of immunotherapy called PD-1 inhibitors. Researchers will analyze blood and tumor tissue samples from 800 patients, both past and future, to develop a scoring system. The goal is to help doctors choose the right treatment for the right patient.

What this could mean

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

Active substance
PD-1 inhibitor (with or without chemotherapy)
What this could lead to
If successful, this could help doctors predict which patients with squamous cell carcinoma will benefit from PD-1 inhibitors, leading to more personalized treatment.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers identified may not prove useful in practice, and results may not apply to all patients.

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.

Participants

About 800 people

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

Started

Sep 2025

Expected to finish

Jul 2027

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.

Who is studied

This study enrolls patients with confirmed squamous cell carcinoma (SCC), including esophageal, head/neck, cervical, and lung subtypes, regardless of resectability. Participants must be scheduled for neoadjuvant or first-line PD-1 inhibitor therapy and provide pretreatment tumor and blood samples. Key inclusion requires capacity for informed consent; concurrent malignancies or prior anticancer treatments are exclusions. All subjects must provide written informed consent and undergo baseline assessments: clinical data collection, archival/fresh tumor tissue acquisition (within 6 months), and peripheral blood sampling (within 28 days) for biomarker analysis.

Ages

18 years and older

Sex

Anyone

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. Patients with pathologically confirmed esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), cervical squamous cell carcinoma (CSCC), or lung squamous cell carcinoma (LSCC), regardless of surgical eligibility 2. For surgically eligible patients: Planned to receive neoadjuvant PD-1 inhibitor ± chemotherapy as first-line treatment 3. For surgically ineligible patients: Planned to receive PD-1 inhibitor ± chemotherapy as first-line treatment 4. Availability of pre-treatment biopsy tissue and baseline blood samples 5. Capable of providing informed consent Exclusion Criteria: 1. Patients with concurrent other types of malignancies 2. Patients who have already undergone prior antitumor therapy

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Conditions

The condition(s) this trial relates to.

cervical squamous cell carcinoma esophageal squamous cell carcinoma head and neck squamous cell carcinoma squamous cell lung carcinoma

As listed by the trial registrant

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

Cervical squamous cell carcinoma Esophageal squamous cell carcinoma (ESCC) Head and neck squamous carcinoma Lung squamous cell carcinoma

Contacts and locations

Locations

  • Department of Etiology and Carcinogenesis

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

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