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New hope for rare, aggressive cancer: drug cocktail shows promise in trial

NCT ID NCT02820857

Disease control Sponsor: Hospices Civils de Lyon 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested whether adding the drug bevacizumab (Avastin) to standard chemotherapy (Folfiri) helps people with advanced, aggressive neuroendocrine carcinoma live longer after their first treatment stops working. The trial included 153 adults with inoperable cancer that started in the digestive tract or an unknown location. The main goal was to see how many patients were alive six months after starting the new treatment.

What this could mean

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

Active substance
bevacizumab (Avastin) plus Folfiri (a chemotherapy combination)
What this could lead to
If successful, this could provide a new second-line treatment option for patients with advanced neuroendocrine carcinoma, potentially extending survival.
What could go wrong
This is a Phase 2 trial with a modest sample size, so results may not be definitive. The combination may not improve survival over Folfiri alone and could cause side effects like bleeding or high blood pressure.

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

153 people

The number who actually took part.

Started

Sep 2017

Finished

Aug 2024

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 years and older

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: * Man or woman aged ≥ 18 years old, * Poorly differentiated neuroendocrine carcinoma (NEC) from a gastrointestinal tract (from esophagus to anal canal) and biliopancreatic primary or an unknown primary cancer, locally advanced and/or metastatic, * Centralized review of the diagnostic by a consulting pathologist specializing in NET (TENPATH network), * Recommendation of a second-line chemotherapy after progression, documented using the RECIST criteria v.1.1, and after a first-line chemotherapy treatment by cisplatin (or carboplatin) + etoposide or in the event of progression in the 6 months following the discontinuation of this first-line treatment, * Recommendation of a second-line chemotherapy for the refractory patient or contraindicated for platinum-etoposide chemotherapy * Patients presenting at least one measurable target lesion according to the RECIST criteria v.1.1, in an area not previously irradiated, * General condition ≤ 2 (WHO), * Patient of child bearing age accepting to use an effective contraception during treatment and until 6 months after the last administration, * Patient who signed the informed consent form. Exclusion Criteria: 1. Relating to the tumor, the patient, and previous treatment: * Well differentiated neuroendocrine tumor * Mixed tumor, except if the NEC component is \> 70%, the patient is eligible, * First-line chemotherapy other than cisplatin (or carboplatin) and etoposide, * All malignant disease in the three years before randomization, with the exception of basal cell carcinoma or in situ cancer treated for curative purposes, * A pregnant or breastfeeding woman, * Lack of efficient contraception (for men or women of reproductive age), * All medical, geographical, social, and psychological conditions or a legal situation that will not allow the patient to finish the study or sign an informed consent form, 2. Relating to the chemotherapy (Folfiri): * Any of the following uncontrolled progressive diseases in the 6 months before randomization: liver failure, renal insufficiency, respiratory distress, congestive heart failure (NYHA III-IV), unstable angina, myocardial infarction, significant arrhythmia, * Known deficiency in dihydropyrimidine dehydrogenase, * Known Gilbert's syndrome, * Total bilirubin level \>1.5x the upper limit of normal (ULN); AST (Aspartate transaminase) and/or ALT (Alanine transaminase) \>5x ULN; TP \<50%; * Neutrophils \<1.5x109/l, platelets \<100x109/l, hemoglobin \<9 g/dl, * Chronic uncontrolled diarrhea, unresolved intestinal occlusion or subocclusion, * History of anaphylactic reaction or known intolerance to atropine (sulfate) or to loperamide or to antiemetics administered in association with Folfiri, * All treatment with concomitant anticonvulsive agents, CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), discontinued for at least 7 days, 3. Relating to bevacizumab: * Uncontrolled brain metastases (by local treatment), * All uncontrolled progressive disease within 1 month prior to randomization: grade 3-4 gastrointestinal bleeding (peptic ulcer, erosive esophagitis or gastritis), infectious disease or intestinal inflammation, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event, * Uncontrolled high blood pressure defined as a systolic blood pressure \>140 mmHg or diastolic pressure \>90 mmHg, * Patients receiving anticoagulant treatment with an unstable dose of a vitamin K antagonist treatment, and/or having an abnormal INR (\>3) in the four weeks before the randomization, * Verified proteinuria above or equal to 1g/24 hours measured from 24 hours of urine if the urinary protein dipstick control is above or equal to 2+, * Creatinine clearance (MDRD) \<50 ml/min. * Hypersensitivity to the active substance or to any of the excipients. * Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm neuroendocrine carcinoma

As listed by the trial registrant

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

Neuroendocrine carcinomas

Contacts and locations

Locations

  • Département d'Oncologie Médicale, Hôpital Saint-Antoine

    Paris, 75012, France

  • Département d'Oncologie Médicale, Institut Paoli Calmettes

    Marseille, 13009, France

  • Département de Cancérologie Urologique et Digestive, Centre Oscar Lambret

    Lille, 59020, France

  • Département de cancérologie médicale - Groupe des tumeurs endocrines, Centre Léon Bérard

    Lyon, 69008, France

  • Pôle Régional de Cancérologie, CHU de Poitiers

    Poitiers, 86021, France

  • Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Européen Georges Pompidou, APHP

    Paris, 75015, France

  • Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Sud, CHU d'Amiens

    Amiens, 80054, France

  • Service d'Hépato-Gastroentérologie et Cancérologie, Hôpital Robert Debré, CHU de Reims

    Reims, 51100, France

  • Service d'Hépato-Gastroentérologie et Oncologie Digestive, CHU de Dijon

    Dijon, 21000, France

  • Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital Haut Lévêque, CHU Bordeaux

    Pessac, 33604, France

  • Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital de la Timone, APHM

    Marseille, 13365, France

  • Service d'Hépatogastroentéologie, Hôpital Michallon, CHU de Grenoble

    Grenoble, 38043, France

  • Service d'Hépatogastroentérologie, CHR d'Orléans

    Orléans, 45067, France

  • Service d'Hépatogastroentérologie, CHU d'Angers

    Angers, 49933, France

  • Service d'Hépatogastroentérologie, Hôpital Pontchaillou, CHU de Rennes

    Rennes, 35000, France

  • Service d'Oncologie Endocrinienne, Institut Gustave Roussy

    Villejuif, 94805, France

  • Service d'Oncologie Médicale - Hôpital Edouard Herriot - Hospices Civils de Lyon

    Lyon, 69437, France

  • Service d'Oncologie Médicale, Hôpital Civil, CHU de Strasbourg

    Strasbourg, 67200, France

  • Service d'Oncologie Médicale, Hôpital Saint Eloi, CHU de Montpellier

    Montpellier, 34298, France

  • Service d'Oncologie et Radiothérapie, Institut Sainte Catherine

    Avignon, 84918, France

  • Service de Gastro-Entérologie, Hôpital Nord, CHU de ST-Etienne

    Saint-Priest-en-Jarez, 42270, France

  • Service de Gastroentérologie et Oncologie Digestive, Hôpital Avicenne

    Bobigny, 93000, France

  • Service de Gastroentérologie et Pancréatologie, Hôpital Beaujon, APHP

    Clichy, 92118, France

  • Service de Gastroentérologie, CHU Henri Mondor

    Créteil, 94000, France

  • Service de Gastroentérologie, CHU de Rouen

    Rouen, 76031, France

  • Service de Gastroentérologie, Hôpital Cochin, APHP

    Paris, 75014, France

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